EQUUS CABALLUS SKIN- horse epithelia injection, solutionCEIBA PENTANDRA FIBER- kapok injection, solutionMUS MUSCULUS SKIN- mouse epithelia injection, solutionORRIS- iris x germanica root injection, solutionRABBIT injection, solutionPERIPLANETA AMERICANA- american cockroach injec .......SE DUST injection, solutionBOS TAURUS SKIN- cattle epithelia injection, solutionCOTTON FIBER- cotton linters injection, solutionCOTTON SEED- cottonseed injection, solutionCANIS LUPUS FAMILIARIS SKIN- dog epithelia injection, solutionCAVIA PORCELLUS SKIN- guinea pig epithelia injection, solution

1. No Title 1572550560
3. Warning
4. Description
5. Clinical Pharmacology
6. Indications And Usage
7. Contraindications
8. Warnings
9. Precautions
10. Adverse Reactions
11. Overdosage
12. Dosage And Administration
13. How Supplied
14. References
15. No Title 1572449379

No Title 1572550560 ⮝

Principal Display Panel
Allergenic Extract
mL sterile multiple dose vial
ALK ABELLO

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0630 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0630-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0631 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0631-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0631-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0632 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0632-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0656 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0656-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0656-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CEIBA PENTANDRA FIBER kapok injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0635 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (CEIBA PENTANDRA FIBER - UNII:758Z9H9WV9) CEIBA PENTANDRA FIBER 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0635-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0635-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUS MUSCULUS SKIN mouse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0638 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0638-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0638-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUS MUSCULUS SKIN mouse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0639 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0639-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ORRIS iris x germanica root injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0642 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRIS X GERMANICA ROOT (UNII: 8N6VTJ9IWV) (IRIS X GERMANICA ROOT - UNII:8N6VTJ9IWV) IRIS X GERMANICA ROOT 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0642-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0642-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RABBIT rabbit injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0649 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0649-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RABBIT rabbit injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0650 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0650-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0650-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RABBIT rabbit injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0651 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0651-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0651-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0705 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0705-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0706 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0706-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0706-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0707 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0707-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0707-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0708 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0708-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0709 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0709-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0710 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0710-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PERIPLANETA AMERICANA american cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0711 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0711-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0714 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0714-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0714-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0715 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0715-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0716 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0716-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0717 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0717-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0718 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0718-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0719 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0719-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0719-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0720 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0720-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BLATELLA GERMANICA german cockroach injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0721 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 500 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0721-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACREMONIUM STRICTUM sarocladium strictum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0800 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0800-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACREMONIUM STRICTUM sarocladium strictum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0801 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0801-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0801-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACREMONIUM STRICTUM sarocladium strictum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0802 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0802-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACREMONIUM STRICTUM sarocladium strictum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0803 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (UNII: 3F36V0451W) (SAROCLADIUM STRICTUM - UNII:3F36V0451W) SAROCLADIUM STRICTUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0803-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0803-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0805 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0805-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0806 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0806-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0807 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0807-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0807-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0808 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0808-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0808-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0809 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0809-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0809-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0810 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0810-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0811 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.01 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0811-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0812 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0812-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0812-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0813 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 0.02 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0813-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0814 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0814-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0815 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0815-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0815-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA TENUIS alternaria tenuis injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0816 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0816-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0816-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0817 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0817-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0817-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:0268-0817-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0818 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0818-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0818-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0819 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0819-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0819-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0820 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0820-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0821 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0821-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0822 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0822-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0823 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.02 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0823-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0824 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0824-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0825 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0825-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0825-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0826 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0826-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0826-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS NIGER VAR NIGER aspergillus niger injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0827 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0827-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0827-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS NIGER VAR NIGER aspergillus niger injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0828 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0828-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0828-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS NIGER VAR NIGER aspergillus niger injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0829 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0829-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS NIGER VAR NIGER aspergillus niger injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0830 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0830-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0830-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS VAR PULLULANS pullularia pullulans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0832 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0832-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0832-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:0268-0832-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS VAR PULLULANS pullularia pullulans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0833 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0833-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0833-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS VAR PULLULANS pullularia pullulans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0834 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0834-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0834-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS VAR PULLULANS pullularia pullulans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0835 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0835-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0835-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS VAR PULLULANS pullularia pullulans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0836 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0836-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0836-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0837 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0837-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0837-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0838 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0838-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0839 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0839-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0840 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0840-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0840-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0841 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0841-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0842 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.01 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0842-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0843 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0843-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0843-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0844 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0844-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0844-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0845 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0845-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0845-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0846 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0846-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0847 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0847-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0848 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 0.02 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0848-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0849 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0849-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0849-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0850 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0850-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHAETOMIUM GLOBOSUM chaetomium globosum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0851 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0851-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0851-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHAETOMIUM GLOBOSUM chaetomium globosum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0852 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0852-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0852-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHAETOMIUM GLOBOSUM chaetomium globosum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0853 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0853-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0853-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0855 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0855-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0855-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0856 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0856-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0856-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0857 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0857-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0857-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0858 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0858-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0859 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.01 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0859-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0860 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0860-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0861 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0861-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0861-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0863 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0863-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0863-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0864 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0864-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0864-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0865 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0865-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0865-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0866 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0866-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0867 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0867-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0868 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0868-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0868-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0869 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0869-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0870 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0870-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0870-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM SPHAEROSPERMUM cladosporium sphaerospermum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0871 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM SPHAEROSPERMUM (UNII: P87YCA1U8R) (CLADOSPORIUM SPHAEROSPERMUM - UNII:P87YCA1U8R) CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0871-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0871-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0878 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0878-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0878-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0879 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0879-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0879-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0880 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0880-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0880-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0881 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0881-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0882 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0882-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0882-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COCHLIOBOLUS SATIVUS helminthosporium sorokinianum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0883 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0883-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0884 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0884-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0884-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:0268-0884-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0885 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0885-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0885-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0886 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0886-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0886-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0887 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0887-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0888 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0888-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0889 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0889-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0890 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.025 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0890-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0891 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0891-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0892 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0892-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0892-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0893 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0893-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0894 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0894-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0894-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0895 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0895-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0895-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0896 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0896-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0896-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0897 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0897-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0898 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0898-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0899 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0899-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0899-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0900 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0900-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0901 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0901-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0901-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FUSARIUM OXYSPORUM VASINFECTUM fusarium vasinfectum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0902 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0902-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0902-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HELMINTHOSPORIUM SOLANI helminthosporium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0903 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0903-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HELMINTHOSPORIUM SOLANI helminthosporium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0904 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0904-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HELMINTHOSPORIUM SOLANI helminthosporium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0905 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0905-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HELMINTHOSPORIUM SOLANI helminthosporium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0906 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0906-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0911 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0911-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0911-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0912 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0912-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0912-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0913 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0913-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0913-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0914 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0914-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0914-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0915 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0915-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0915-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

NEUROSPORA INTERMEDIA neurospora intermedia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0916 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0916-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0916-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

NEUROSPORA INTERMEDIA neurospora intermedia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0917 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0917-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0917-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

NEUROSPORA INTERMEDIA neurospora intermedia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0918 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0918-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

NEUROSPORA INTERMEDIA neurospora intermedia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0919 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0919-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0919-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

NEUROSPORA INTERMEDIA neurospora intermedia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0920 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA INTERMEDIA (UNII: 2072U60DUI) (NEUROSPORA INTERMEDIA - UNII:2072U60DUI) NEUROSPORA INTERMEDIA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0920-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0921 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0921-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0921-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0922 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0922-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0922-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0923 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0923-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0923-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0924 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0924-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0925 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0925-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM penicillium chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0926 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0926-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0926-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0928 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0928-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0928-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0929 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0929-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0929-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0930 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0930-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0930-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0932 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0932-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0932-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0933 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0933-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PHOMA EXIGUA VAR EXIGUA phoma herbarum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0931 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0931-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHIZOPUS ARRHIZUS VAR ARRHIZUS rhizopus batatas injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0934 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0934-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0934-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHIZOPUS ARRHIZUS VAR ARRHIZUS rhizopus batatas injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0935 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0935-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0935-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHIZOPUS ARRHIZUS VAR ARRHIZUS rhizopus batatas injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0936 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0936-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0936-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHIZOPUS ARRHIZUS VAR ARRHIZUS rhizopus batatas injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0937 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS ARRHIZUS VAR. ARRHIZUS (UNII: 8476849N1Y) (RHIZOPUS ARRHIZUS VAR. ARRHIZUS - UNII:8476849N1Y) RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0937-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0937-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0939 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0939-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0939-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0940 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0940-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0941 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0941-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0942 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0942-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0943 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0943-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0943-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA RUBRA rhodotorula rubra injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0944 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA RUBRA (UNII: 15W81V867R) (RHODOTORULA RUBRA - UNII:15W81V867R) RHODOTORULA RUBRA 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0944-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

USTILAGO MAYDIS corn smut injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0945 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0945-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0945-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

USTILAGO MAYDIS corn smut injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0946 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0946-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

USTILAGO TRITICI loose wheat smut injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0952 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO TRITICI (UNII: BV82OL2IZ8) (USTILAGO TRITICI - UNII:BV82OL2IZ8) USTILAGO TRITICI 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0952-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0952-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

STEMPHYLIUM SOLANI stemphylium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0955 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0955-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0955-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

STEMPHYLIUM SOLANI stemphylium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0956 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0956-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0956-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

STEMPHYLIUM SOLANI stemphylium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0957 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0957-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0957-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

STEMPHYLIUM SOLANI stemphylium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0958 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0958-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

STEMPHYLIUM SOLANI stemphylium solani injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0959 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SOLANI (UNII: 1IEK4UDP5M) (STEMPHYLIUM SOLANI - UNII:1IEK4UDP5M) STEMPHYLIUM SOLANI 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0959-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0959-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0961 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0961-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0961-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0962 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0962-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0962-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0963 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0963-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0965 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0965-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0966 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0966-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0967 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0967-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0967-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SACCHAROMYCES CEREVISIAE saccharomyces cerevisiae injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0968 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0968-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SACCHAROMYCES CEREVISIAE saccharomyces cerevisiae injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0969 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0969-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACACIA acacia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1000 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1000-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1000-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACACIA acacia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1001 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1001-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AILANTHUS ALTISSIMA POLLEN ailanthus tree of heaven injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1004 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALNUS INCANA SSP RUGOSA POLLEN alder white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1007 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1007-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALNUS INCANA SSP RUGOSA POLLEN alder white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1008 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1008-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALNUS INCANA SSP RUGOSA POLLEN alder white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1009 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS INCANA SUBSP. RUGOSA POLLEN (UNII: 605T96G8Y5) (ALNUS INCANA SUBSP. RUGOSA POLLEN - UNII:605T96G8Y5) ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MEDICAGO SATIVA POLLEN alfalfa injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1012 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MEDICAGO SATIVA POLLEN alfalfa injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1013 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS VELUTINA POLLEN ash arizona injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1016 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1016-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS VELUTINA POLLEN ash arizona injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1017 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1017-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1017-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:0268-1017-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS VELUTINA POLLEN ash arizona injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1018 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1018-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1021 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1021-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1022 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1022-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1022-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1023 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1023-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1023-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1024 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1024-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1024-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1025 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1025-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FRAXINUS AMERICANA POLLEN ash white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1026 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1026-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS TREMULOIDES POLLEN aspen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1029 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1029-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1029-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS TREMULOIDES POLLEN aspen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1030 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1030-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1030-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1033 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1033-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1034 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1034-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1034-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1035 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1035-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1035-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1036 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1036-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1036-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1037 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1037-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PASPALUM NOTATUM POLLEN bahia grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1038 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1038-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORELLA CERIFERA POLLEN bayberry wax myrtle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1041 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1041-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1041-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORELLA CERIFERA POLLEN bayberry wax myrtle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1042 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1042-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1042-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORELLA CERIFERA POLLEN bayberry wax myrtle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1043 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1043-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FAGUS GRANDIFOLIA POLLEN beech injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1046 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1046-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1046-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FAGUS GRANDIFOLIA POLLEN beech injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1047 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1047-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1047-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FAGUS GRANDIFOLIA POLLEN beech injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1048 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1048-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1048-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

FAGUS GRANDIFOLIA POLLEN beech injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1049 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1049-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1056 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1056-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1056-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1057 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1057-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1057-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1058 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1058-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1059 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 50000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1059-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA NIGRA POLLEN birch river red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1062 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1062-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1062-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA NIGRA POLLEN birch river red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1063 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1063-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1063-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA NIGRA POLLEN birch river red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1064 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1064-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA NIGRA POLLEN birch river red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1065 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1065-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA NIGRA POLLEN birch river red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1066 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1066-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1066-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1069 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1069-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1069-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1070 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1070-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1070-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1071 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1071-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1072 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1072-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BETULA LENTA POLLEN birch white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1073 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1073-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1073-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POA ANNUA POLLEN bluegrass annual injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1076 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1076-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POA ANNUA POLLEN bluegrass annual injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1077 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1077-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER NEGUNDO POLLEN box elder ash leaf maple injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1080 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1080-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1080-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER NEGUNDO POLLEN box elder ash leaf maple injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1081 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1081-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1081-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER NEGUNDO POLLEN box elder ash leaf maple injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1082 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1082-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1082-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER NEGUNDO POLLEN box elder ash leaf maple injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1083 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1083-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BROMUS INERMIS POLLEN brome grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1086 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1086-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1086-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BROMUS INERMIS POLLEN brome grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1087 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1087-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1087-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BROMUS INERMIS POLLEN brome grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1089 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1089-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS PALMERI POLLEN carelessweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1092 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1092-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1092-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS PALMERI POLLEN carelessweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1093 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 0.025 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1093-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1093-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS PALMERI POLLEN carelessweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1094 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1094-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS ASHEI POLLEN cedar mountain injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1097 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1097-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1097-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS ASHEI POLLEN cedar mountain injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1098 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1098-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1098-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS ASHEI POLLEN cedar mountain injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1099 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1099-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1099-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1102 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1102-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1102-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1103 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1103-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1103-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1104 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1104-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1105 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1105-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1106 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1106-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1106-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1107 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1107-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1110 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1110-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1110-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1111 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1111-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1111-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1112 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1112-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1112-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1113 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1113-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1114 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1114-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1115 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1115-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1116 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1116-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

XANTHIUM STRUMARIUM VAR CANADENSE POLLEN cocklebur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1117 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN (UNII: 0ZK6G3W3BI) (XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - UNII:0ZK6G3W3BI) XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1117-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ZEA MAYS POLLEN corn pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1120 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1120-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1120-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ZEA MAYS POLLEN corn pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1121 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1121-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1121-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ZEA MAYS POLLEN corn pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1122 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1122-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ZEA MAYS POLLEN corn pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1123 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 500 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1123-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1126 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1126-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1126-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1127 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1127-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1127-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1128 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1128-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1128-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1129 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1129-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1129-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1130 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1130-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS FREMONTII POLLEN cottonwood fremont injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1133 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1133-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS FREMONTII POLLEN cottonwood fremont injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1134 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1134-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS FREMONTII POLLEN cottonwood fremont injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1135 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS FREMONTII POLLEN (UNII: 426RHB4302) (POPULUS FREMONTII POLLEN - UNII:426RHB4302) POPULUS FREMONTII POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1135-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES SSP MONILIFERA POLLEN cottonwood western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1138 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1138-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES SSP MONILIFERA POLLEN cottonwood western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1139 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - UNII:5928LJ1441) POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1139-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1139-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CUPRESSUS ARIZONICA POLLEN cypress arizona injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1142 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1142-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CUPRESSUS ARIZONICA POLLEN cypress arizona injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1143 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1143-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1143-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TAXODIUM DISTICHUM POLLEN cypress bald injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1146 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1146-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1146-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TAXODIUM DISTICHUM POLLEN cypress bald injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1147 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1147-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1147-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TAXODIUM DISTICHUM POLLEN cypress bald injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1148 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1148-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1151 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1151-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1151-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1152 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1152-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1152-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1153 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1153-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1153-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1154 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1154-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1155 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1155-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1155-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1156 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 60000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1156-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX CRISPUS POLLEN dock yellow injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1159 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1159-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1159-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX CRISPUS POLLEN dock yellow injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1160 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1160-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1160-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX CRISPUS POLLEN dock yellow injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1161 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1161-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1161-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUPATORIUM CAPILLIFOLIUM POLLEN dog fennel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1164 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1164-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1164-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUPATORIUM CAPILLIFOLIUM POLLEN dog fennel non stock injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1165 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (EUPATORIUM CAPILLIFOLIUM POLLEN - UNII:B67NF86HF0) EUPATORIUM CAPILLIFOLIUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1165-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1165-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1168 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1168-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1168-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1169 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1169-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1169-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1170 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1170-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1170-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1171 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1171-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1172 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1172-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1607 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1607-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1174 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1174-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS CRASSIFOLIA POLLEN elm cedar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1177 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1177-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS CRASSIFOLIA POLLEN elm cedar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1178 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1178-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS PUMILA POLLEN elm chinese injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1181 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1181-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1181-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS PUMILA POLLEN elm chinese injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1182 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1182-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1182-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUCALYPTUS GLOBULUS POLLEN eucalyptus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1185 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1185-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUCALYPTUS GLOBULUS POLLEN eucalyptus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1186 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1186-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1186-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUCALYPTUS GLOBULUS POLLEN eucalyptus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1187 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1187-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EUCALYPTUS GLOBULUS POLLEN eucalyptus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1188 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1188-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1191 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1191-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1192 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1192-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1192-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1193 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1193-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1608 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1608-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1195 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1195-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1195-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CELTIS OCCIDENTALIS POLLEN hackberry injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1198 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1198-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1198-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CELTIS OCCIDENTALIS POLLEN hackberry injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1199 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1199-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1199-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CELTIS OCCIDENTALIS POLLEN hackberry injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1200 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1200-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CORYLUS AMERICANA POLLEN hazelnut pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1203 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1203-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CORYLUS AMERICANA POLLEN hazelnut pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1204 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1204-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1204-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CORYLUS AMERICANA POLLEN hazelnut pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1205 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1205-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CORYLUS AMERICANA POLLEN hazelnut pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1206 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORYLUS AMERICANA POLLEN (UNII: ZGS382Y3AV) (CORYLUS AMERICANA POLLEN - UNII:ZGS382Y3AV) CORYLUS AMERICANA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1206-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1214 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1214-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1214-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1215 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1215-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1215-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1216 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1216-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1216-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1217 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1217-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1218 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1218-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1219 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1219-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SORGHUM HALEPENSE POLLEN johnson grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1220 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1220-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS CALIFORNICA POLLEN juniper western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1223 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1223-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS CALIFORNICA POLLEN juniper western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1224 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1224-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1224-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS CALIFORNICA POLLEN juniper western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1225 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1225-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1225-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

KOCHIA SCOPARIA POLLEN kochia firebush injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1232 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1232-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1232-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

KOCHIA SCOPARIA POLLEN kochia firebush injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1233 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1233-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1233-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

KOCHIA SCOPARIA POLLEN kochia firebush injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1234 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1234-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1234-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

KOCHIA SCOPARIA POLLEN kochia firebush injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1235 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (BASSIA SCOPARIA POLLEN - UNII:07A108ZKW5) BASSIA SCOPARIA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1235-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1238 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1238-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1238-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1239 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1239-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1239-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1240 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1240-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1240-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1241 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1241-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1242 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1242-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ROBINIA PSEUDOACACIA POLLEN locust black non stock injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1245 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (ROBINIA PSEUDOACACIA POLLEN - UNII:8003NOJ82F) ROBINIA PSEUDOACACIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1245-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER RUBRUM POLLEN maple red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1248 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1248-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1248-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER RUBRUM POLLEN maple red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1249 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1249-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1249-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER SACCHARUM POLLEN maple sugar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1252 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1252-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1252-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER SACCHARUM POLLEN maple sugar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1253 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1253-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1253-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER SACCHARUM POLLEN maple sugar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1254 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1254-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1254-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ACER SACCHARUM POLLEN maple sugar injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1255 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1255-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA XANTHIFOLIA POLLEN marshelder burweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1258 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1258-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1258-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA XANTHIFOLIA POLLEN marshelder burweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1259 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1259-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1259-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA XANTHIFOLIA POLLEN marshelder burweed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1260 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (CYCLACHAENA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) CYCLACHAENA XANTHIFOLIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1260-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1260-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA ANNUA VAR ANNUA POLLEN marshelder rough injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1263 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1263-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1263-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA ANNUA VAR ANNUA POLLEN marshelder rough injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1264 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1264-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1264-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA ANNUA VAR ANNUA POLLEN marshelder rough injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1265 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1265-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1265-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

IVA ANNUA VAR ANNUA POLLEN marshelder rough injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1266 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1266-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MELALEUCA QUINQUENERVIA POLLEN melaleuca pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1273 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1273-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1273-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MELALEUCA QUINQUENERVIA POLLEN melaleuca pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1274 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1274-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1274-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MELALEUCA QUINQUENERVIA POLLEN melaleuca pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1275 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1275-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MELALEUCA QUINQUENERVIA POLLEN melaleuca pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1276 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (MELALEUCA QUINQUENERVIA POLLEN - UNII:NX974IRT8E) MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1276-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1276-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PROSOPIS JULIFLORA POLLEN mesquite injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1279 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1279-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1279-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PROSOPIS JULIFLORA POLLEN mesquite injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1280 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1280-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1280-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PROSOPIS JULIFLORA POLLEN mesquite injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1281 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1281-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM AMBROSIOIDES POLLEN mexican tea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1284 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1284-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1284-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

CHENOPODIUM AMBROSIOIDES POLLEN mexican tea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1285 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1285-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1285-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

CHENOPODIUM AMBROSIOIDES POLLEN mexican tea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1286 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.025 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1286-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1286-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

ARTEMISIA VULGARIS POLLEN mugwort common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1297 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1297-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1297-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA VULGARIS POLLEN mugwort common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1298 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1298-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1298-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA VULGARIS POLLEN mugwort common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1299 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1299-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1299-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA VULGARIS POLLEN mugwort common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1300 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1300-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1300-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA VULGARIS POLLEN mugwort common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1301 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1301-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS RUBRA POLLEN mulberry red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1304 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1304-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1304-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS RUBRA POLLEN mulberry red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1305 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1305-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1305-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS RUBRA POLLEN mulberry red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1306 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1306-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1306-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS RUBRA POLLEN mulberry red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1307 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1307-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS ALBA POLLEN mulberry white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1310 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1310-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1310-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MORUS ALBA POLLEN mulberry white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1311 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1311-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1311-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS AGRIFOLIA POLLEN oak california live coast injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1314 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1314-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1314-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS AGRIFOLIA POLLEN oak california live coast injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1315 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1315-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1315-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS RUBRA POLLEN oak red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1318 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1318-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1318-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS RUBRA POLLEN oak red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1319 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1319-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1319-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS VIRGINIANA POLLEN oak virginia live injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1322 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1322-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1322-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS VIRGINIANA POLLEN oak virginia live injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1323 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1323-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1323-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS VIRGINIANA POLLEN oak virginia live injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1324 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1324-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1327 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1327-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1327-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1328 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1328-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1328-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1329 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1329-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1329-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1330 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1330-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1613 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1613-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1332 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 50000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1332-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1333 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1333-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oat wild pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1336 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1336-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1336-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

OLEA EUROPAEA POLLEN olive pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1339 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1339-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1339-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

OLEA EUROPAEA POLLEN olive pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1340 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1340-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1340-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SYAGRUS ROMANZOFFIANA POLLEN palm queen coco palm injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1347 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1347-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1347-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SYAGRUS ROMANZOFFIANA POLLEN palm queen coco palm injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1348 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1348-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1348-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1354 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1354-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1354-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1355 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1355-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1355-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1614 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1614-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1358 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1358-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SCHINUS MOLLE POLLEN pepper tree california injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1361 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (SCHINUS MOLLE POLLEN - UNII:M0G28FH9K1) SCHINUS MOLLE POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1361-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1361-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1364 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1364-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1364-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1365 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1365-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1365-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1366 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1366-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1366-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1367 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1367-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1368 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1368-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS SPINOSUS POLLEN pigweed spiny injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1371 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1371-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1371-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS SPINOSUS POLLEN pigweed spiny injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1372 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1372-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1372-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS SPINOSUS POLLEN pigweed spiny injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1373 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1373-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CASUARINA EQUISETIFOLIA POLLEN pine australian beefwood injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1376 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1376-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1376-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CASUARINA EQUISETIFOLIA POLLEN pine australian beefwood injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1377 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1377-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1377-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CASUARINA EQUISETIFOLIA POLLEN pine australian beefwood injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1378 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1378-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CASUARINA EQUISETIFOLIA POLLEN pine australian beefwood injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1379 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASUARINA EQUISETIFOLIA POLLEN (UNII: OZJ4OE173N) (CASUARINA EQUISETIFOLIA POLLEN - UNII:OZJ4OE173N) CASUARINA EQUISETIFOLIA POLLEN 50000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1379-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1379-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS STROBUS POLLEN pine white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1382 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1382-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1382-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS STROBUS POLLEN pine white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1383 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1383-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1383-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS STROBUS POLLEN pine white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1384 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1384-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS STROBUS POLLEN pine white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1385 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1385-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS STROBUS POLLEN pine white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1386 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 500 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1386-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS ECHINATA POLLEN pine yellow injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1389 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1389-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1389-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PINUS ECHINATA POLLEN pine yellow injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1390 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS ECHINATA POLLEN (UNII: 96LRW14765) (PINUS ECHINATA POLLEN - UNII:96LRW14765) PINUS ECHINATA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1390-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1390-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1394 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1394-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1394-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1395 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1395-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1395-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1396 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1396-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1397 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1397-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1397-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1616 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1399 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1399-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1399-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1400 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1400-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1400-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1401 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1401-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1402 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1402-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS ALBA POLLEN poplar white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1405 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1405-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1405-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS ALBA POLLEN poplar white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1406 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1406-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1406-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS ALBA POLLEN poplar white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1407 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1407-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1407-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS ALBA POLLEN poplar white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1408 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1408-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS ALBA POLLEN poplar white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1409 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1409-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIGUSTRUM VULGARE POLLEN privet injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1412 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1412-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1412-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIGUSTRUM VULGARE POLLEN privet injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1413 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1413-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1413-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIGUSTRUM VULGARE POLLEN privet injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1414 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1414-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIGUSTRUM VULGARE POLLEN privet injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1415 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1415-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 08/01/2017

ELYMUS REPENS POLLEN quack grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1418 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1418-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1418-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ELYMUS REPENS POLLEN quack grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1419 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1419-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ELYMUS REPENS POLLEN quack grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1420 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1420-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ACANTHICARPA POLLEN ragweed false bur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1423 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1423-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1423-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ACANTHICARPA POLLEN ragweed false bur injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1424 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1424-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1424-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TENUIFOLIA POLLEN ragweed slender injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1431 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1431-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TENUIFOLIA POLLEN ragweed slender injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1432 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TENUIFOLIA POLLEN (UNII: 57W5SO585B) (AMBROSIA TENUIFOLIA POLLEN - UNII:57W5SO585B) AMBROSIA TENUIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1432-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA BIDENTATA POLLEN ragweed southern injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1435 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1435-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1435-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA BIDENTATA POLLEN ragweed southern injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1436 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (AMBROSIA BIDENTATA POLLEN - UNII:M3S672G75O) AMBROSIA BIDENTATA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1436-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1436-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ARTEMISIIFOLIA POLLEN ragweed short injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1531 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1531-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1531-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ARTEMISIIFOLIA POLLEN ragweed short injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1532 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1532-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1532-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ARTEMISIIFOLIA POLLEN ragweed short injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1533 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1533-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA ARTEMISIIFOLIA POLLEN ragweed short injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1534 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1534-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1534-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TRIFIDA POLLEN ragweed tall giant injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1439 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1439-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1439-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TRIFIDA POLLEN ragweed tall giant injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1440 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1440-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1440-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TRIFIDA POLLEN ragweed tall giant injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1441 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1441-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA TRIFIDA POLLEN ragweed tall giant injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1442 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1442-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA PSILOSTACHYA POLLEN ragweed western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1445 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1445-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1445-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMBROSIA PSILOSTACHYA POLLEN ragweed western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1446 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1446-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1446-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALSOLA KALI POLLEN russian thistle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1453 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1453-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1453-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALSOLA KALI POLLEN russian thistle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1454 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1454-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1454-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALSOLA KALI POLLEN russian thistle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1455 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1455-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1455-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALSOLA KALI POLLEN russian thistle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1456 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1456-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALSOLA KALI POLLEN russian thistle injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1457 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1457-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LOLIUM PERENNE SSP MULTIFLORUM POLLEN rye grass italian injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1460 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOLIUM MULTIFLORUM POLLEN (UNII: VJI0WKK736) (LOLIUM MULTIFLORUM POLLEN - UNII:VJI0WKK736) LOLIUM MULTIFLORUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1460-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA FRIGIDA POLLEN sage prairie injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1467 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1467-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA FRIGIDA POLLEN sage prairie injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1468 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1468-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1468-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA TRIDENTATA POLLEN sagebrush common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1471 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1471-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1471-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA TRIDENTATA POLLEN sagebrush common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1472 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1472-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1472-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA TRIDENTATA POLLEN sagebrush common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1473 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1473-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

DISTICHLIS SPICATA POLLEN salt grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1476 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1476-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1476-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

DISTICHLIS SPICATA POLLEN salt grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1477 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (DISTICHLIS SPICATA POLLEN - UNII:GOA51670YV) DISTICHLIS SPICATA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1477-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1477-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ATRIPLEX WRIGHTII POLLEN saltbush annual atriplex injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1480 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1480-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1480-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ATRIPLEX WRIGHTII POLLEN saltbush annual atriplex injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1481 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 0.025 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1481-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1481-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1493 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1493-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1493-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1494 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1494-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1494-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1495 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1495-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1496 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1496-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1497 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1497-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

LIQUIDAMBAR STYRACIFLUA POLLEN sweetgum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1498 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1498-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLATANUS OCCIDENTALIS POLLEN sycamore american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1501 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1501-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1501-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLATANUS OCCIDENTALIS POLLEN sycamore american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1502 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1502-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1502-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLATANUS OCCIDENTALIS POLLEN sycamore american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1503 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1503-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1503-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLATANUS OCCIDENTALIS POLLEN sycamore american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1504 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1504-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLATANUS OCCIDENTALIS POLLEN sycamore american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1505 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1505-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HOLCUS LANATUS POLLEN velvet grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1510 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1510-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1510-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

HOLCUS LANATUS POLLEN velvet grass injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1511 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (HOLCUS LANATUS POLLEN - UNII:70O1TP6H01) HOLCUS LANATUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1511-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS NIGRA POLLEN walnut black pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1512 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1512-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1512-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS NIGRA POLLEN walnut black pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1513 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1513-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1513-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS NIGRA POLLEN walnut black pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1514 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1514-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1514-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS NIGRA POLLEN walnut california black pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1515 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1515-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS REGIA POLLEN walnut english pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1516 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1516-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUGLANS REGIA POLLEN walnut english pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1517 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS REGIA POLLEN (UNII: ARW43087I1) (JUGLANS REGIA POLLEN - UNII:ARW43087I1) JUGLANS REGIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1517-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1517-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS TUBERCULATUS POLLEN water hemp injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1518 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1518-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1518-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS TUBERCULATUS POLLEN water hemp injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1519 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 0.025 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1519-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1519-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS TUBERCULATUS POLLEN water hemp injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1520 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1520-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1520-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AMARANTHUS TUBERCULATUS POLLEN water hemp injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1521 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1521-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRITICUM AESTIVUM POLLEN wheat pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1522 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1522-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1522-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRITICUM AESTIVUM POLLEN wheat pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1523 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1523-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1523-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1524 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1524-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1524-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1525 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1525-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1525-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1526 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1526-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1526-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1527 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1527-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1527-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1528 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1528-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SALIX NIGRA POLLEN willow black injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1529 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1529-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ARTEMISIA ANNUA POLLEN wormwood common annual injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1530 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1530-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1530-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1601 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1601-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RABBIT rabbit injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0652 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RABBIT (UNII: O5V0F26RUW) (RABBIT - UNII:O5V0F26RUW) RABBIT 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0652-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS ASHEI POLLEN cedar mountain injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1602 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1602-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1603 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS VIRGINIANA POLLEN cedar red injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1604 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1604-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

POPULUS DELTOIDES POLLEN cottonwood eastern common injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1605 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RUMEX ACETOSELLA POLLEN dock sour sheep sorrel injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1606 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1606-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ULMUS AMERICANA POLLEN elm american injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1173 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1173-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

SOLIDAGO CANADENSIS POLLEN goldenrod injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1194 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1194-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

JUNIPERUS CALIFORNICA POLLEN juniper western injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1609 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS CALIFORNICA POLLEN (UNII: 0H1V4V5V9L) (JUNIPERUS CALIFORNICA POLLEN - UNII:0H1V4V5V9L) JUNIPERUS CALIFORNICA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM ALBUM POLLEN lambs quarters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1610 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1610-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CHENOPODIUM AMBROSIOIDES POLLEN mexican tea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1611 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1611-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-1611-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

QUERCUS AGRIFOLIA POLLEN oak california live coast injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1612 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS AGRIFOLIA POLLEN (UNII: VOT5MA71M7) (QUERCUS AGRIFOLIA POLLEN - UNII:VOT5MA71M7) QUERCUS AGRIFOLIA POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

QUERCUS ALBA POLLEN oak white injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1331 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1331-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1356 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1356-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CARYA ILLINOINENSIS POLLEN pecan pollen injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1357 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1357-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PLANTAGO LANCEOLATA POLLEN plantain english injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1398 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1398-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PYRETHRUM CINERARIIFOLIUM pyrethrum cinerariifolium injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0645 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0645-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PYRETHRUM CINERARIIFOLIUM pyrethrum cinerariifolium injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0646 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0646-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998

AMARANTHUS RETROFLEXUS POLLEN pigweed rough redroot injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1615 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 02/23/1998

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0001 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0001-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0002 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0002-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0003 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0003-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0004 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0004-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0004-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0005 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 40000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0005-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0005-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0006 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0006-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0007 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0007-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0007-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0008 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 500 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0008-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0009 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0009-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0009-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0010 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0010-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0011 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0011-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0011-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0012 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0012-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0012-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

HOUSE DUST house dust injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0013 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0013-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0013-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965 06/30/2013

BOS TAURUS SKIN cattle epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0603 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0603-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0603-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOS TAURUS SKIN cattle epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0604 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0604-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOS TAURUS SKIN cattle epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0605 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0605-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOS TAURUS SKIN cattle epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0606 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0606-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COTTON FIBER cotton linters injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0609 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO) COTTON FIBER 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0609-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0609-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

COTTON SEED cottonseed injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0612 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN) COTTON SEED 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0612-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0615 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0615-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0615-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0616 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 1000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0616-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0617 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0617-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0618 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 100 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0618-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0618-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0619 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0619-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0619-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0620 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 20000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0620-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0620-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0621 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0621-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0621-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0622 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0622-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0623 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.0005 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0623-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0624 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.001 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0624-05 5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0624-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0625 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.01 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0625-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0626 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0626-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0626-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0627 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0627-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANIS LUPUS FAMILIARIS SKIN dog epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-1600 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-1600-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CAVIA PORCELLUS SKIN guinea pig epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0653 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 1 mL PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0653-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0653-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CAVIA PORCELLUS SKIN guinea pig epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0654 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0654-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CAVIA PORCELLUS SKIN guinea pig epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0655 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0655-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0655-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0628 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 0.10 g in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0628-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0628-30 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 3 NDC:0268-0628-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EQUUS CABALLUS SKIN horse epithelia injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-0629 Route of Administration SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 10000 [PNU] in 1 mL

Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) 0.004 mL in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.009 g in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.00275 g in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0268-0629-10 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product 2 NDC:0268-0629-50 50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

Labeler - ALK-Abello, Inc. (809998847)

Revised: 8/2017 Document Id: 8cd1ba48-174c-4aca-8eb9-c2d99b451026 53405-7 Set id: 1e72cad7-cd64-4c32-bf05-76a32b99e874 Version: 6 Effective Time: 20170809 ALK-Abello, Inc.