APPLE injection, solutionAPRICOT injection, solutionAVOCADO injection, solutionBANANA injection, solutionBLACKBERRY injection, solutionBLUEBERRY- blue ridge blueberry injection, solutionCANTALOUPE injection, solutionCHERRY FOOD (cherry) injection, solution OSAGE ORANGE VAR BOIS DARC POLLEN (maclura pomifera pollen) injection, solution LAKE TROUT (trout) injection, solution TUNA injection, solution TURKEY FOOD (turkey) injection, solution BLACK WALNUT FOOD- black walnut injection, solution [Allergy Laboratories, Inc.]OSAGE ORANGE VAR BOIS DARC POLLEN- maclura pomifera pollen injection, solutionLAKE TROUT- trout injection, solutionTUNA injection, solutionTURKEY FOOD- turkey injection, solutionBLACK WALNUT FOOD- black walnut injection, solution

1. No Title 1572548369
2. No Title 1572548370
3. No Title 1572449452
4. Warnings
5. Description
6. Clinical Pharmacology
7. Indications And Usage
8. Contraindications
9. Precautions
10. Adverse Reactions
11. Overdosage
12. Dosage And Administration
13. How Supplied
14. Storage
15. References

No Title 1572548369 ⮝

Allergenic Extracts

Directions for Use

No Title 1572548370 ⮝

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACT

SCRATCH TESTING

RX ONLY

APPLE apple injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-335 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APPLE (UNII: B423VGH5S9) (APPLE - UNII:B423VGH5S9) APPLE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-335-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-335-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-335-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-335-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

APRICOT apricot injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-336 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APRICOT (UNII: 269CJD5GZ9) (APRICOT - UNII:269CJD5GZ9) APRICOT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-336-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-336-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-336-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-336-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

AVOCADO avocado injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-338 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOCADO (UNII: SDS87L369F) (AVOCADO - UNII:SDS87L369F) AVOCADO 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-338-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-338-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-338-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-338-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BANANA banana injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-339 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BANANA (UNII: 4AJZ4765R9) (BANANA - UNII:4AJZ4765R9) BANANA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-339-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-339-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-339-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-339-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACKBERRY blackberry injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-353 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACKBERRY (UNII: 8A6OMU3I8L) (BLACKBERRY - UNII:8A6OMU3I8L) BLACKBERRY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-353-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-353-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-353-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-353-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BLUEBERRY blue ridge blueberry injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-354 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLUE RIDGE BLUEBERRY (UNII: 89Y9MUH0K5) (BLUE RIDGE BLUEBERRY - UNII:89Y9MUH0K5) BLUE RIDGE BLUEBERRY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-354-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-354-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-354-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-354-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CANTALOUPE cantaloupe injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-360 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANTALOUPE (UNII: 8QF5D5H6UH) (CANTALOUPE - UNII:8QF5D5H6UH) CANTALOUPE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-360-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-360-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-360-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-360-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CHERRY FOOD cherry injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-371 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHERRY (UNII: BUC5I9595W) (CHERRY - UNII:BUC5I9595W) CHERRY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-371-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-371-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-371-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-371-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CRANBERRY cranberry injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-383 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRANBERRY (UNII: 0MVO31Q3QS) (CRANBERRY - UNII:0MVO31Q3QS) CRANBERRY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-383-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-383-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-383-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-383-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

DATE date injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-387 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DATE (UNII: H3O7QI5HY7) (DATE - UNII:H3O7QI5HY7) DATE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-387-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-387-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-387-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-387-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BASIL basil injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-341 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASIL (UNII: 2U0KZP0FDW) (BASIL - UNII:2U0KZP0FDW) BASIL 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-341-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-341-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-341-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-341-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GRAPEFRUIT grapefruit injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-399 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GRAPEFRUIT (UNII: O82C39RR8C) (GRAPEFRUIT - UNII:O82C39RR8C) GRAPEFRUIT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-399-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-399-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-399-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-399-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BLACK BASS largemouth bass injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-342 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LARGEMOUTH BASS (UNII: XC209ITL3J) (LARGEMOUTH BASS - UNII:XC209ITL3J) LARGEMOUTH BASS 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-342-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-342-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-342-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-342-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

LEMON lemon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-406 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEMON (UNII: 24RS0A988O) (LEMON - UNII:24RS0A988O) LEMON 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-406-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-406-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-406-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-406-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

LIME lime, citrus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-408 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIME (CITRUS) (UNII: 8CZS546954) (LIME (CITRUS) - UNII:8CZS546954) LIME (CITRUS) 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-408-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-408-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-408-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-408-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

ORANGE FOOD orange injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-423 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORANGE (UNII: 5EVU04N5QU) (ORANGE - UNII:5EVU04N5QU) ORANGE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-423-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-423-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-423-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-423-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PEACH peach injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-432 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEACH (UNII: 3OKE88I3QG) (PEACH - UNII:3OKE88I3QG) PEACH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-432-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-432-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-432-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-432-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PEAR pear injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-434 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEAR (UNII: 2ZN8DWC0YF) (PEAR - UNII:2ZN8DWC0YF) PEAR 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-434-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-434-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-434-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-434-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PINEAPPLE pineapple injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-440 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINEAPPLE (UNII: 2A88ZO081O) (PINEAPPLE - UNII:2A88ZO081O) PINEAPPLE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-440-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-440-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-440-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-440-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PINTO BEAN kidney bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-346 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-346-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-346-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-346-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-346-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BEEF beef injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-350 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEEF (UNII: 4PIB2155QP) (BEEF - UNII:4PIB2155QP) BEEF 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-350-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-350-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-350-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-350-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

STRAWBERRY strawberry injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-462 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRAWBERRY (UNII: 4J2TY8Y81V) (STRAWBERRY - UNII:4J2TY8Y81V) STRAWBERRY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-462-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-462-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-462-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-462-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CATFISH catfish injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-365 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CATFISH (UNII: EFN1AL1YP0) (CATFISH - UNII:EFN1AL1YP0) CATFISH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-365-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-365-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-365-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-365-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

WATERMELON watermelon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-474 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATERMELON (UNII: 231473QB6R) (WATERMELON - UNII:231473QB6R) WATERMELON 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-474-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-474-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-474-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-474-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CHICKEN FOOD chicken injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-372 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHICKEN (UNII: 0X8Q245Y7B) (CHICKEN - UNII:0X8Q245Y7B) CHICKEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-372-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-372-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-372-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-372-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CLAM quahog injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-375 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUAHOG (UNII: 226LY0AFR9) (QUAHOG - UNII:226LY0AFR9) QUAHOG 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-375-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-375-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-375-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-375-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RED KIDNEY BEAN kidney bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-347 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-347-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-347-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-347-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-347-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

LIMA BEAN lima bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-344 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIMA BEAN (UNII: 112YH1ZMX2) (LIMA BEAN - UNII:112YH1ZMX2) LIMA BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-344-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-344-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-344-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-344-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

NAVY BEAN kidney bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-345 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KIDNEY BEAN (UNII: M98C8416QO) (KIDNEY BEAN - UNII:M98C8416QO) KIDNEY BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-345-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-345-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-345-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-345-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GREEN STRING BEAN string bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-349 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STRING BEAN (UNII: N9D69B2Q7Y) (STRING BEAN - UNII:N9D69B2Q7Y) STRING BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-349-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-349-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-349-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-349-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CODFISH cod injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-379 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COD (UNII: 8D6Q5LNG3D) (COD - UNII:8D6Q5LNG3D) COD 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-379-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-379-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-379-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-379-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BROCCOLI broccoli injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-356 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROCCOLI (UNII: UOI4FT57BZ) (BROCCOLI - UNII:UOI4FT57BZ) BROCCOLI 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-356-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-356-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-356-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-356-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CRAB MEAT blue crab injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-382 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLUE CRAB (UNII: 8J18RFO4A8) (BLUE CRAB - UNII:8J18RFO4A8) BLUE CRAB 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-382-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-382-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-382-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-382-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BRUSSEL SPROUTS brussels sprout injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-357 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRUSSELS SPROUT (UNII: KHX46H31F8) (BRUSSELS SPROUT - UNII:KHX46H31F8) BRUSSELS SPROUT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-357-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-357-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-357-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-357-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CABBAGE cabbage injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-359 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CABBAGE (UNII: GW0W1Y9I97) (CABBAGE - UNII:GW0W1Y9I97) CABBAGE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-359-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-359-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-359-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-359-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CARROT carrot injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-362 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARROT (UNII: L56Z1JK48B) (CARROT - UNII:L56Z1JK48B) CARROT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-362-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-362-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-362-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-362-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CAULIFLOWER cauliflower injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-366 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAULIFLOWER (UNII: 138LUT2DWV) (CAULIFLOWER - UNII:138LUT2DWV) CAULIFLOWER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-366-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-366-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-366-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-366-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CELERY celery injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-367 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELERY (UNII: 44IDY6DTKX) (CELERY - UNII:44IDY6DTKX) CELERY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-367-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-367-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-367-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-367-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

EGG WHITE egg white injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-389 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE (UNII: 3E0I92Z2GR) (EGG WHITE - UNII:3E0I92Z2GR) EGG WHITE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-389-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-389-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-389-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-389-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CUCUMBER cucumber injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-385 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUCUMBER (UNII: YY7C30VXJT) (CUCUMBER - UNII:YY7C30VXJT) CUCUMBER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-385-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-385-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-385-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-385-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

WHOLE EGG egg injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-390 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG (UNII: 291P45F896) (EGG - UNII:291P45F896) EGG 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-390-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-390-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-390-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-390-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GREEN PEPPER green bell pepper injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-437 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GREEN BELL PEPPER (UNII: 4J4DOU3HEK) (GREEN BELL PEPPER - UNII:4J4DOU3HEK) GREEN BELL PEPPER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-437-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-437-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-437-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-437-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

EGG YOLK egg yolk injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-391 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK (UNII: 4IPS17B70T) (EGG YOLK - UNII:4IPS17B70T) EGG YOLK 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-391-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-391-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-391-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-391-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

LETTUCE lettuce injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-407 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LETTUCE (UNII: 5PO6NN3RRJ) (LETTUCE - UNII:5PO6NN3RRJ) LETTUCE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-407-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-407-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-407-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-407-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

MUSHROOM FOOD cultivated mushroom injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-414 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CULTIVATED MUSHROOM (UNII: 54C8E6W6JY) (CULTIVATED MUSHROOM - UNII:54C8E6W6JY) CULTIVATED MUSHROOM 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-414-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-414-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-414-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-414-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

FLOUNDER flounder injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-394 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLOUNDER (UNII: T197LO581X) (FLOUNDER - UNII:T197LO581X) FLOUNDER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-394-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-394-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-394-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-394-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GREEN OLIVE green olive injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-420 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GREEN OLIVE (UNII: 6HD2W46UEG) (GREEN OLIVE - UNII:6HD2W46UEG) GREEN OLIVE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-420-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-420-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-420-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-420-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

ONION onion injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-422 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-422-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-422-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-422-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-422-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PARSLEY parsley injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-428 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PARSLEY (UNII: 58FMD0Q0EV) (PARSLEY - UNII:58FMD0Q0EV) PARSLEY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-428-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-428-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-428-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-428-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GREEN PEA pea injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-431 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEA (UNII: W4X7H8GYFM) (PEA - UNII:W4X7H8GYFM) PEA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-431-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-431-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-431-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-431-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SWEET POTATO sweet potato injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-444 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SWEET POTATO (UNII: M9WGG9Z9GK) (SWEET POTATO - UNII:M9WGG9Z9GK) SWEET POTATO 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-444-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-444-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-444-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-444-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

WHITE POTATO potato injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-445 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTATO (UNII: CFE1S8DYWD) (POTATO - UNII:CFE1S8DYWD) POTATO 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-445-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-445-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-445-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-445-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GRAPE concord grape injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-398 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CONCORD GRAPE (UNII: T3PW93IB4Q) (CONCORD GRAPE - UNII:T3PW93IB4Q) CONCORD GRAPE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-398-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-398-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-398-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-398-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

RADISH radish injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-449 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463) RADISH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-449-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-449-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-449-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-449-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

RHUBARB rhubarb injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-451 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E) RHUBARB 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-451-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-451-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-451-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-451-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SOYBEAN soybean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-348 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD) SOYBEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-348-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-348-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-348-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-348-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SPINACH spinach injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-460 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPINACH (UNII: 6WO75C6WVB) (SPINACH - UNII:6WO75C6WVB) SPINACH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-460-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-460-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-460-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-460-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

YELLOW SQUASH squash injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-461 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SQUASH (UNII: 9961HBA483) (SQUASH - UNII:9961HBA483) SQUASH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-461-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-461-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-461-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-461-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

TOMATO tomato injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-466 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOMATO (UNII: Z4KHF2C175) (TOMATO - UNII:Z4KHF2C175) TOMATO 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-466-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-466-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-466-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-466-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

HADDOCK haddock injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-400 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HADDOCK (UNII: 0WLY635722) (HADDOCK - UNII:0WLY635722) HADDOCK 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-400-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-400-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-400-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-400-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

HALIBUT pacific halibut injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-401 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PACIFIC HALIBUT (UNII: BKZ683617P) (PACIFIC HALIBUT - UNII:BKZ683617P) PACIFIC HALIBUT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-401-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-401-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-401-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-401-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

COW MILK cow milk injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-412 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-412-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-412-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-412-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-412-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CASHEW NUT cashew injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-364 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASHEW (UNII: 3H5U5CX7KO) (CASHEW - UNII:3H5U5CX7KO) CASHEW 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-364-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-364-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-364-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-364-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

COCONUT coconut injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-378 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCONUT (UNII: 3RT3536DHY) (COCONUT - UNII:3RT3536DHY) COCONUT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-378-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-378-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-378-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-378-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

ENGLISH WALNUT FOOD english walnut injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-473 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-473-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-473-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-473-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-473-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BLACK PEPPER black pepper injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-436 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-436-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-436-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-436-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-436-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PEANUT FOOD peanut injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-433 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEANUT (UNII: QE1QX6B99R) (PEANUT - UNII:QE1QX6B99R) PEANUT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-433-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-433-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-433-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-433-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PECAN FOOD pecan injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-435 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECAN (UNII: F14P91GB5F) (PECAN - UNII:F14P91GB5F) PECAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-435-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-435-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-435-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-435-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PERCH perch injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-438 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERCH (UNII: 50Y07N9X03) (PERCH - UNII:50Y07N9X03) PERCH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-438-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-438-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-438-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-438-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BARLEY FOOD barley injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-340 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-340-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-340-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-340-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-340-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BUCKWHEAT buckwheat injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-358 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUCKWHEAT (UNII: N0Y68724R3) (BUCKWHEAT - UNII:N0Y68724R3) BUCKWHEAT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-358-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-358-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-358-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-358-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

OATS FOOD oat injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-418 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-418-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-418-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-418-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-418-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

RICE FOOD rice injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-452 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RICE (UNII: 659G217HPG) (RICE - UNII:659G217HPG) RICE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-452-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-452-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-452-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-452-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

RYE FOOD rye injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-453 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X) RYE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-453-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-453-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-453-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-453-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

WHOLE WHEAT FOOD wheat injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-476 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y) WHEAT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-476-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-476-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-476-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-476-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PIMENTO red bell pepper injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-439 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RED BELL PEPPER (UNII: E917XHH50V) (RED BELL PEPPER - UNII:E917XHH50V) RED BELL PEPPER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-439-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-439-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-439-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-439-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PORK pork injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-443 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK (UNII: O138UB266J) (PORK - UNII:O138UB266J) PORK 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-443-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-443-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-443-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-443-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PACIFIC SALMON pink salmon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-455 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINK SALMON (UNII: 9935G0V38C) (PINK SALMON - UNII:9935G0V38C) PINK SALMON 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-455-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-455-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-455-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-455-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PAPAYA papaya injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-426 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PAPAYA (UNII: KU94FIY6JB) (PAPAYA - UNII:KU94FIY6JB) PAPAYA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-426-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-426-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-426-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-426-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SCALLOP scallop injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-456 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SCALLOP (UNII: D380C73WOU) (SCALLOP - UNII:D380C73WOU) SCALLOP 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-456-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-456-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-456-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-456-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SHRIMP shrimp injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-458 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SHRIMP (UNII: 1891LE191T) (SHRIMP - UNII:1891LE191T) SHRIMP 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-458-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-458-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-458-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-458-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SUNFLOWER SEED sunflower seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-463 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z) SUNFLOWER SEED 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-463-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-463-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-463-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-463-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BLACKEYED PEA black-eyed pea injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-430 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK-EYED PEA (UNII: 786YV7B602) (BLACK-EYED PEA - UNII:786YV7B602) BLACK-EYED PEA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-430-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-430-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-430-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-430-50 10 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CORN FOOD corn injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-381 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O) CORN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-381-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-381-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-381-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-381-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CACAO BEAN cocoa injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-377 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA (UNII: D9108TZ9KG) (COCOA - UNII:D9108TZ9KG) COCOA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-377-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-377-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-377-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-377-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

COFFEE FOR DIAGNOSTIC USE ONLY coffee bean injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-380 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744) COFFEE BEAN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-380-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-380-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-380-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-380-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BARLEY MALT barley malt injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-410 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARLEY MALT (UNII: R3NBG8914U) (BARLEY MALT - UNII:R3NBG8914U) BARLEY MALT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-410-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-410-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-410-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-410-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CINNAMON cinnamon injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-374 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-374-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-374-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-374-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-374-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

DILL SEED dill injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-388 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILL (UNII: Y05PC4JZRH) (DILL - UNII:Y05PC4JZRH) DILL 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-388-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-388-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-388-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-388-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GARLIC garlic injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-395 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-395-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-395-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-395-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-395-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

GINGER ginger injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-397 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-397-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-397-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-397-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-397-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

HORSERADISH horseradish injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-405 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-405-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-405-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-405-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-405-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

MUSTARD SEED mustard seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-415 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUSTARD SEED (UNII: 58RXI817UT) (MUSTARD SEED - UNII:58RXI817UT) MUSTARD SEED 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-415-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-415-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-415-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-415-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

OREGANO oregano injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-424 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OREGANO (UNII: 0E5AT8T16U) (OREGANO - UNII:0E5AT8T16U) OREGANO 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-424-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-424-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-424-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-424-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PEPPERMINT peppermint injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-486 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEPPERMINT (UNII: V95R5KMY2B) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-486-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-486-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-486-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-486-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

POPPY SEED poppy seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-442 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPPY SEED (UNII: 60RO23IR87) (POPPY SEED - UNII:60RO23IR87) POPPY SEED 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-442-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-442-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-442-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-442-50 10 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SAGE FOOD sage injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-454 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-454-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-454-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-454-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-454-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SESAME SEED sesame seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-457 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR) SESAME SEED 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-457-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-457-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-457-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-457-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

SPEARMINT spearmint injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-459 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPEARMINT (UNII: J7I2T6IV1N) (SPEARMINT - UNII:J7I2T6IV1N) SPEARMINT 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-459-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-459-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-459-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-459-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

THYME thyme injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-465 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THYME (UNII: CW657OBU4N) (THYME - UNII:CW657OBU4N) THYME 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-465-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-465-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-465-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-465-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

VANILLA vanilla injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-471 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANILLA (UNII: Q74T35078H) (VANILLA - UNII:Q74T35078H) VANILLA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL WATER (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-471-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-471-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-471-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-471-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

ALMOND almond injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-333 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALMOND (UNII: 3Z252A2K9G) (ALMOND - UNII:3Z252A2K9G) ALMOND 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-333-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-333-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-333-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-333-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ACACIA POLLEN acacia injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-901 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACACIA (UNII: 5C5403N26O) (ACACIA - UNII:5C5403N26O) ACACIA 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-901-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-901-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-901-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-901-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RED ALDER POLLEN alnus rubra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-902 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H) ALNUS RUBRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-902-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-902-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-902-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-902-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SMOOTH ALDER POLLEN alnus incana subsp. rugosa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-903 Route of Administration PERCUTANEOUS, 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 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-903-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-903-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-903-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-903-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ARIZONA ASH POLLEN fraxinus velutina pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-904 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (FRAXINUS VELUTINA POLLEN - UNII:LJT6I6Z8FD) FRAXINUS VELUTINA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-904-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-904-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-904-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-904-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GREEN RED ASH POLLEN fraxinus pennsylvanica pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-905 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX) (FRAXINUS PENNSYLVANICA POLLEN - UNII:2WZG2G15WX) FRAXINUS PENNSYLVANICA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-905-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-905-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-905-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-905-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE ASH POLLEN fraxinus americana pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-906 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-906-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-906-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-906-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-906-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ASH MIX, GREEN/WHITE POLLEN fraxinus americana pollen and fraxinus pennsylvanica pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-907 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (FRAXINUS AMERICANA POLLEN - UNII:G684LX721Q) FRAXINUS AMERICANA POLLEN 0.5 g in 20 mL FRAXINUS PENNSYLVANICA POLLEN (UNII: 2WZG2G15WX) (FRAXINUS PENNSYLVANICA POLLEN - UNII:2WZG2G15WX) FRAXINUS PENNSYLVANICA POLLEN 0.5 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-907-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-907-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-907-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-907-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

QUAKING ASPEN POLLEN populus tremuloides pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-908 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS TREMULOIDES POLLEN (UNII: 928OC2TJDA) (POPULUS TREMULOIDES POLLEN - UNII:928OC2TJDA) POPULUS TREMULOIDES POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-908-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-908-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-908-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-908-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BAYBERRY POLLEN morella cerifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-909 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORELLA CERIFERA POLLEN (UNII: LC8MEV9S89) (MORELLA CERIFERA POLLEN - UNII:LC8MEV9S89) MORELLA CERIFERA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-909-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-909-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-909-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-909-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

AMERICAN BEECH POLLEN fagus grandifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-910 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (FAGUS GRANDIFOLIA POLLEN - UNII:34X886W1H4) FAGUS GRANDIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-910-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-910-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-910-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-910-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BOX ELDER POLLEN acer negundo pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-914 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (ACER NEGUNDO POLLEN - UNII:P6K070AR8V) ACER NEGUNDO POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-914-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-914-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-914-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-914-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

MOUNTAIN CEDAR POLLEN juniperus ashei pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-915 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (JUNIPERUS ASHEI POLLEN - UNII:544F8MEY0Y) JUNIPERUS ASHEI POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-915-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-915-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-915-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-915-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PINCHOT CEDAR POLLEN juniperus pinchotii pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-916 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS PINCHOTII POLLEN (UNII: S8A4X05W7J) (JUNIPERUS PINCHOTII POLLEN - UNII:S8A4X05W7J) JUNIPERUS PINCHOTII POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-916-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-916-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-916-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-916-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RED CEDAR POLLEN juniperus virginiana pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-917 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-917-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-917-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-917-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-917-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

EASTERN COTTONWOOD POLLEN populus deltoides pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-919 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-919-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-919-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-919-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-919-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WESTERN COTTONWOOD POLLEN populus deltoides subsp. monilifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-920 Route of Administration PERCUTANEOUS, 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 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-920-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-920-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-920-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-920-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

COTTONWOOD MIX, EASTERN/WESTERN POLLEN populus deltoides subsp. monilifera pollen and populus deltoides pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-921 Route of Administration PERCUTANEOUS, 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 0.5 g in 20 mL POPULUS DELTOIDES POLLEN (UNII: 476DVV63WP) (POPULUS DELTOIDES POLLEN - UNII:476DVV63WP) POPULUS DELTOIDES POLLEN 0.5 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-921-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-921-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-921-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-921-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ARIZONA CYPRESS POLLEN cupressus arizonica pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-922 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CUPRESSUS ARIZONICA POLLEN (UNII: 232DMH0XVF) (CUPRESSUS ARIZONICA POLLEN - UNII:232DMH0XVF) CUPRESSUS ARIZONICA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-922-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-922-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-922-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-922-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BALD CYPRESS POLLEN taxodium distichum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-923 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (TAXODIUM DISTICHUM POLLEN - UNII:O12H03B41R) TAXODIUM DISTICHUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-923-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-923-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-923-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-923-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

AMERICAN ELM POLLEN ulmus americana pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-924 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-924-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-924-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-924-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-924-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CEDAR FALL BLOOMING ELM POLLEN ulmus crassifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-925 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS CRASSIFOLIA POLLEN (UNII: G82398SD3I) (ULMUS CRASSIFOLIA POLLEN - UNII:G82398SD3I) ULMUS CRASSIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-925-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-925-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-925-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-925-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CHINESE SIBERIAN ELM POLLEN ulmus pumila pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-926 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-926-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-926-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-926-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-926-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ELM MIX, AMERICAN/CHINESE/SLIPPERY POLLEN ulmus pumila pollen and ulmus americana pollen and ulmus rubra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-928 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ULMUS PUMILA POLLEN (UNII: 030R993R8E) (ULMUS PUMILA POLLEN - UNII:030R993R8E) ULMUS PUMILA POLLEN 0.33 g in 20 mL ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN 0.33 g in 20 mL ULMUS RUBRA POLLEN (UNII: GHC6OHK0W0) (ULMUS RUBRA POLLEN - UNII:GHC6OHK0W0) ULMUS RUBRA POLLEN 0.34 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-928-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-928-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-928-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-928-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

EUCALYPTUS BLUE GUM POLLEN eucalyptus globulus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-929 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (EUCALYPTUS GLOBULUS POLLEN - UNII:7XW7TB10X9) EUCALYPTUS GLOBULUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-929-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-929-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-929-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-929-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

DOUGLAS FIR POLLEN pseudotsuga menziesii pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-930 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOTSUGA MENZIESII POLLEN (UNII: ZEI09763J3) (PSEUDOTSUGA MENZIESII POLLEN - UNII:ZEI09763J3) PSEUDOTSUGA MENZIESII POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-930-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-930-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-930-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-930-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SWEETGUM POLLEN liquidambar styraciflua pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-932 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (LIQUIDAMBAR STYRACIFLUA POLLEN - UNII:5Q246DS5BS) LIQUIDAMBAR STYRACIFLUA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-932-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-932-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-932-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-932-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

HACKBERRY POLLEN celtis occidentalis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-933 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (CELTIS OCCIDENTALIS POLLEN - UNII:68R9X9Y96X) CELTIS OCCIDENTALIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-933-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-933-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-933-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-933-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SHAGBARK HICKORY POLLEN carya ovata pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-935 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-935-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-935-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-935-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-935-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE HICKORY POLLEN carya tomentosa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-936 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA TOMENTOSA POLLEN (UNII: G2A764T54B) (CARYA TOMENTOSA POLLEN - UNII:G2A764T54B) CARYA TOMENTOSA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-936-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-936-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-936-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-936-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

HICKORY MIX, PIGNUT/SHAGBARK/SHELLBARK/WHITE POLLEN carya tomentosa pollen and carya laciniosa pollen and carya ovata pollen and carya glabra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-937 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA TOMENTOSA POLLEN (UNII: G2A764T54B) (CARYA TOMENTOSA POLLEN - UNII:G2A764T54B) CARYA TOMENTOSA POLLEN 0.25 g in 20 mL CARYA LACINIOSA POLLEN (UNII: 5BGG872373) (CARYA LACINIOSA POLLEN - UNII:5BGG872373) CARYA LACINIOSA POLLEN 0.25 g in 20 mL CARYA OVATA POLLEN (UNII: 54UN9R2798) (CARYA OVATA POLLEN - UNII:54UN9R2798) CARYA OVATA POLLEN 0.25 g in 20 mL CARYA GLABRA POLLEN (UNII: KPO1Z9N98A) (CARYA GLABRA POLLEN - UNII:KPO1Z9N98A) CARYA GLABRA POLLEN 0.25 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-937-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-937-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-937-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-937-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ONE SEED JUNIPER POLLEN juniperus monosperma pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-938 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS MONOSPERMA POLLEN (UNII: PM6E3FG1QK) (JUNIPERUS MONOSPERMA POLLEN - UNII:PM6E3FG1QK) JUNIPERUS MONOSPERMA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-938-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-938-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-938-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-938-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ROCKY MOUNTAIN JUNIPER POLLEN juniperus scopulorum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-939 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUNIPERUS SCOPULORUM POLLEN (UNII: 0G82TT8ZFY) (JUNIPERUS SCOPULORUM POLLEN - UNII:0G82TT8ZFY) JUNIPERUS SCOPULORUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-939-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-939-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-939-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-939-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RIVER BIRCH POLLEN betula nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-912 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-912-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-912-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-912-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-912-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-913 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA NIGRA POLLEN (UNII: 93963RFO1P) (BETULA NIGRA POLLEN - UNII:93963RFO1P) BETULA NIGRA POLLEN 0.25 g in 20 mL BETULA PAPYRIFERA POLLEN (UNII: 3538FNV8AY) (BETULA PAPYRIFERA POLLEN - UNII:3538FNV8AY) BETULA PAPYRIFERA POLLEN 0.25 g in 20 mL BETULA LENTA POLLEN (UNII: JQ5HI5004M) (BETULA LENTA POLLEN - UNII:JQ5HI5004M) BETULA LENTA POLLEN 0.25 g in 20 mL BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 0.25 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-913-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-913-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-913-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-913-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE GRAY BIRCH POLLEN betula populifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-940 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETULA POPULIFOLIA POLLEN (UNII: 23H70FYJ5U) (BETULA POPULIFOLIA POLLEN - UNII:23H70FYJ5U) BETULA POPULIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-940-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-940-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-940-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-940-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SUGAR HARD MAPLE POLLEN acer saccharum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-941 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-941-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-941-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-941-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-941-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

MAPLE MIX, RED/SILVER/SUGAR POLLEN acer saccharum pollen and acer saccharinum pollen and acer rubrum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-943 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN 0.33 g in 20 mL ACER SACCHARINUM POLLEN (UNII: 95447163DG) (ACER SACCHARINUM POLLEN - UNII:95447163DG) ACER SACCHARINUM POLLEN 0.33 g in 20 mL ACER RUBRUM POLLEN (UNII: 700NK45C76) (ACER RUBRUM POLLEN - UNII:700NK45C76) ACER RUBRUM POLLEN 0.34 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-943-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-943-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-943-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-943-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

MESQUITE POLLEN prosopis juliflora pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-944 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (PROSOPIS JULIFLORA POLLEN - UNII:6EIJ3D04MR) PROSOPIS JULIFLORA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-944-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-944-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-944-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-944-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PAPER MULBERRY POLLEN broussonetia papyrifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-945 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROUSSONETIA PAPYRIFERA POLLEN (UNII: 51I6N3XIML) (BROUSSONETIA PAPYRIFERA POLLEN - UNII:51I6N3XIML) BROUSSONETIA PAPYRIFERA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-945-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-945-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-945-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-945-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RED MULBERRY POLLEN morus rubra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-946 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (MORUS RUBRA POLLEN - UNII:9LYI4RTZ52) MORUS RUBRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-946-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-946-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-946-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-946-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE MULBERRY POLLEN morus alba pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-947 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MORUS ALBA POLLEN (UNII: 3I9T68187H) (MORUS ALBA POLLEN - UNII:3I9T68187H) MORUS ALBA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-947-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-947-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-947-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-947-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACK OAK POLLEN quercus velutina pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-948 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VELUTINA POLLEN (UNII: 294L626TT0) (QUERCUS VELUTINA POLLEN - UNII:294L626TT0) QUERCUS VELUTINA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-948-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-948-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-948-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-948-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACKJACK OAK POLLEN quercus nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-949 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS NIGRA POLLEN (UNII: 6U600U1326) (QUERCUS NIGRA POLLEN - UNII:6U600U1326) QUERCUS NIGRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-949-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-949-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-949-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-949-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BUR OAK POLLEN quercus macrocarpa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-950 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS MACROCARPA POLLEN (UNII: 57BTU4547U) (QUERCUS MACROCARPA POLLEN - UNII:57BTU4547U) QUERCUS MACROCARPA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-950-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-950-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-950-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-950-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

LIVE OAK POLLEN quercus virginiana pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-951 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (QUERCUS VIRGINIANA POLLEN - UNII:8KDG09A4GO) QUERCUS VIRGINIANA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-951-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-951-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-951-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-951-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

2-OAK MIX, RED/WHITE POLLEN quercus rubra pollen and quercus alba pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-952 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.5 g in 20 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.5 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-952-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-952-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-952-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-952-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

5-OAK MIX, BLACKJACK/BUR/POST/RED/WHITE POLLEN quercus nigra pollen and quercus macrocarpa pollen and quercus stellata pollen and quercus rubra pollen and quercus alba pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-954 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS NIGRA POLLEN (UNII: 6U600U1326) (QUERCUS NIGRA POLLEN - UNII:6U600U1326) QUERCUS NIGRA POLLEN 0.20 g in 20 mL QUERCUS MACROCARPA POLLEN (UNII: 57BTU4547U) (QUERCUS MACROCARPA POLLEN - UNII:57BTU4547U) QUERCUS MACROCARPA POLLEN 0.20 g in 20 mL QUERCUS STELLATA POLLEN (UNII: W34X0P8636) (QUERCUS STELLATA POLLEN - UNII:W34X0P8636) QUERCUS STELLATA POLLEN 0.20 g in 20 mL QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (QUERCUS RUBRA POLLEN - UNII:SVW19ET93C) QUERCUS RUBRA POLLEN 0.20 g in 20 mL QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 0.20 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-954-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-954-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-954-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-954-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

3-OAK MIX, BLACK/BLACKJACK/POST POLLEN quercus velutina pollen and quercus nigra pollen and quercus stellata pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-953 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS VELUTINA POLLEN (UNII: 294L626TT0) (QUERCUS VELUTINA POLLEN - UNII:294L626TT0) QUERCUS VELUTINA POLLEN 0.33 g in 20 mL QUERCUS NIGRA POLLEN (UNII: 6U600U1326) (QUERCUS NIGRA POLLEN - UNII:6U600U1326) QUERCUS NIGRA POLLEN 0.33 g in 20 mL QUERCUS STELLATA POLLEN (UNII: W34X0P8636) (QUERCUS STELLATA POLLEN - UNII:W34X0P8636) QUERCUS STELLATA POLLEN 0.34 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-953-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-953-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-953-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-953-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

POST OAK POLLEN quercus stellata pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-955 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS STELLATA POLLEN (UNII: W34X0P8636) (QUERCUS STELLATA POLLEN - UNII:W34X0P8636) QUERCUS STELLATA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-955-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-955-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-955-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-955-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

QUEEN PALM POLLEN syagrus romanzoffiana pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-956 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (SYAGRUS ROMANZOFFIANA POLLEN - UNII:84ZOM591BB) SYAGRUS ROMANZOFFIANA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-956-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-956-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-956-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-956-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

EUROPEAN OLIVE POLLEN olea europaea pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-957 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (OLEA EUROPAEA POLLEN - UNII:43R41XZ627) OLEA EUROPAEA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-957-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-957-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-957-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-957-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

DATE PALM POLLEN phoenix dactylifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-959 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOENIX DACTYLIFERA POLLEN (UNII: 2FV55IRB5B) (PHOENIX DACTYLIFERA POLLEN - UNII:2FV55IRB5B) PHOENIX DACTYLIFERA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-959-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-959-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-959-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-959-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PECAN POLLEN carya illinoinensis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-960 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (CARYA ILLINOINENSIS POLLEN - UNII:PYO4JR720Y) CARYA ILLINOINENSIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-960-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-960-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-960-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-960-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE PINE POLLEN pinus strobus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-962 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-962-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-962-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-962-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-962-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

4-PINE MIX, AUSTRIAN/LOBLOLLY/SCOTCH/WHITE POLLEN pinus strobus pollen and pinus sylvestris pollen and pinus taeda pollen and pinus nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-963 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (PINUS STROBUS POLLEN - UNII:TX1ER5UV3T) PINUS STROBUS POLLEN 0.25 g in 20 mL PINUS SYLVESTRIS POLLEN (UNII: 59070I8M63) (PINUS SYLVESTRIS POLLEN - UNII:59070I8M63) PINUS SYLVESTRIS POLLEN 0.25 g in 20 mL PINUS TAEDA POLLEN (UNII: 4O1FFR8ARN) (PINUS TAEDA POLLEN - UNII:4O1FFR8ARN) PINUS TAEDA POLLEN 0.25 g in 20 mL PINUS NIGRA POLLEN (UNII: 17Q05812N1) (PINUS NIGRA POLLEN - UNII:17Q05812N1) PINUS NIGRA POLLEN 0.25 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-963-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-963-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-963-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-963-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

LOMBARDY POPLAR POLLEN populus nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-964 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS NIGRA POLLEN (UNII: 0MGE63QPFJ) (POPULUS NIGRA POLLEN - UNII:0MGE63QPFJ) POPULUS NIGRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-964-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-964-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-964-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-964-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE POPLAR POLLEN populus alba pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-965 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS NIGRA POLLEN - UNII:0MGE63QPFJ) POPULUS ALBA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-965-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-965-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-965-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-965-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PRIVET POLLEN ligustrum vulgare pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-966 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (LIGUSTRUM VULGARE POLLEN - UNII:Y3FRX92Z0E) LIGUSTRUM VULGARE POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-966-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-966-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-966-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-966-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLUE SPRUCE POLLEN picea pungens pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-967 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PICEA PUNGENS POLLEN (UNII: R9JBC6687X) (PICEA PUNGENS POLLEN - UNII:R9JBC6687X) PICEA PUNGENS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-967-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-967-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-967-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-967-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

UPLAND SUMAC POLLEN rhus glabra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-968 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHUS GLABRA POLLEN (UNII: 5THQ6K6J4O) (RHUS GLABRA POLLEN - UNII:5THQ6K6J4O) RHUS GLABRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-968-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-968-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-968-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-968-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SYCAMORE POLLEN platanus occidentalis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-969 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (PLATANUS OCCIDENTALIS POLLEN - UNII:E03U1K03LK) PLATANUS OCCIDENTALIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-969-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-969-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-969-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-969-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

TREE OF HEAVEN POLLEN ailanthus altissima pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-970 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AILANTHUS ALTISSIMA POLLEN (UNII: 2A64U81OQ3) (AILANTHUS ALTISSIMA POLLEN - UNII:2A64U81OQ3) AILANTHUS ALTISSIMA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-970-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-970-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-970-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-970-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACK WALNUT POLLEN juglans nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-971 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (JUGLANS NIGRA POLLEN - UNII:1BV28146ZR) JUGLANS NIGRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-971-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-971-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-971-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-971-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACK WILLOW POLLEN salix nigra pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-972 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (SALIX NIGRA POLLEN - UNII:6M2JIH93ZN) SALIX NIGRA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-972-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-972-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-972-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-972-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PUSSY WILLOW POLLEN salix discolor pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-973 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALIX DISCOLOR POLLEN (UNII: ER172J09FM) (SALIX DISCOLOR POLLEN - UNII:ER172J09FM) SALIX DISCOLOR POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-973-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-973-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-973-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-973-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLACK LOCUST POLLEN robinia pseudoacacia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-974 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROBINIA PSEUDOACACIA POLLEN (UNII: 8003NOJ82F) (ROBINIA PSEUDOACACIA POLLEN - UNII:8003NOJ82F) ROBINIA PSEUDOACACIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-974-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-974-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-974-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-974-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WHITE OAK POLLEN quercus alba pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-978 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (QUERCUS ALBA POLLEN - UNII:Z4Y9ZSV4KK) QUERCUS ALBA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-978-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-978-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-978-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-978-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BAHIA GRASS POLLEN paspalum notatum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-081 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-081-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-081-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-081-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-081-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CULTIVATED BARLEY POLLEN hordeum vulgare pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-082 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORDEUM VULGARE POLLEN (UNII: 2LN3M29LNI) (HORDEUM VULGARE POLLEN - UNII:2LN3M29LNI) HORDEUM VULGARE POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-082-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-082-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-082-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-082-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CREEPING BENT GRASS POLLEN agrostis stolonifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-083 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AGROSTIS STOLONIFERA POLLEN (UNII: 255H8VT4RK) (AGROSTIS STOLONIFERA POLLEN - UNII:255H8VT4RK) AGROSTIS STOLONIFERA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-083-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-083-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-083-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-083-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ANNUAL BLUEGRASS POLLEN poa annua pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-085 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POA ANNUA POLLEN (UNII: 7U437HHU5C) (POA ANNUA POLLEN - UNII:7U437HHU5C) POA ANNUA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-085-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-085-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-085-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-085-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

HUNGARIAN SMOOTH BROME POLLEN bromus inermis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-088 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS INERMIS POLLEN (UNII: 766QT72BK6) (BROMUS INERMIS POLLEN - UNII:766QT72BK6) BROMUS INERMIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-088-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-088-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-088-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-088-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CANARY GRASS POLLEN phalaris minor pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-089 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHALARIS MINOR POLLEN (UNII: VBT3DRA2R9) (PHALARIS MINOR POLLEN - UNII:VBT3DRA2R9) PHALARIS MINOR POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-089-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-089-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-089-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-089-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SOUTHERN CHEAT CHESS POLLEN bromus secalinus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-090 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMUS SECALINUS POLLEN (UNII: Q4T1SJ3046) (BROMUS SECALINUS POLLEN - UNII:Q4T1SJ3046) BROMUS SECALINUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-090-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-090-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-090-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-090-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CULTIVATED CORN POLLEN zea mays pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-091 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZEA MAYS POLLEN (UNII: 74PD8J616H) (ZEA MAYS POLLEN - UNII:74PD8J616H) ZEA MAYS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-091-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-091-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-091-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-091-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BLUE GRAMA GRASS bouteloua gracilis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-093 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOUTELOUA GRACILIS POLLEN (UNII: 2XO08315X1) (BOUTELOUA GRACILIS POLLEN - UNII:2XO08315X1) BOUTELOUA GRACILIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-093-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-093-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-093-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-093-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

JOHNSON GRASS POLLEN sorghum halepense pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-094 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-094-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-094-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-094-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-094-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

TALL OAT GRASS POLLEN arrhenatherum elatius pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-095 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARRHENATHERUM ELATIUS POLLEN (UNII: B55BD1QM4Q) (ARRHENATHERUM ELATIUS POLLEN - UNII:B55BD1QM4Q) ARRHENATHERUM ELATIUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-095-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-095-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-095-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-095-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CULTIVATED OATS POLLEN avena sativa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-096 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (AVENA SATIVA POLLEN - UNII:A7IKY24TR7) AVENA SATIVA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-096-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-096-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-096-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-096-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

QUACK GRASS POLLEN elymus repens pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-098 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELYMUS REPENS POLLEN (UNII: ON2T85TA2O) (ELYMUS REPENS POLLEN - UNII:ON2T85TA2O) ELYMUS REPENS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-098-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-098-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-098-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-098-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ITALIAN RYEGRASS POLLEN lolium perenne subsp. multiflorum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-101 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOLIUM PERENNE SUBSP. MULTIFLORUM POLLEN (UNII: VJI0WKK736) (LOLIUM PERENNE SUBSP. MULTIFLORUM POLLEN - UNII:VJI0WKK736) LOLIUM PERENNE SUBSP. MULTIFLORUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-101-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-101-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-101-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-101-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GRAIN SORGHUM POLLEN sorghum bicolor subsp. bicolor pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-104 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM BICOLOR SUBSP. BICOLOR POLLEN (UNII: LD795V73G4) (SORGHUM BICOLOR SUBSP. BICOLOR POLLEN - UNII:LD795V73G4) SORGHUM BICOLOR SUBSP. BICOLOR POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-104-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-104-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-104-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-104-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SUDAN GRASS POLLEN sorghum bicolor subsp. drummondii pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-105 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN (UNII: B43R30VP73) (SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN - UNII:B43R30VP73) SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-105-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-105-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-105-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-105-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CULTIVATED WHEAT POLLEN triticum aestivum pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-109 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (TRITICUM AESTIVUM POLLEN - UNII:F1KAH8374D) TRITICUM AESTIVUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-109-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-109-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-109-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-109-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WESTERN WHEAT POLLEN pascopyrum smithii pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-110 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASCOPYRUM SMITHII POLLEN (UNII: 6AU0ZD8T1O) (PASCOPYRUM SMITHII POLLEN - UNII:6AU0ZD8T1O) PASCOPYRUM SMITHII POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-110-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-110-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-110-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-110-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ALFALFA POLLEN medicago sativa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-113 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEDICAGO SATIVA POLLEN (UNII: G515RAI9FY) (MEDICAGO SATIVA POLLEN - UNII:G515RAI9FY) MEDICAGO SATIVA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-113-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-113-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-113-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-113-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SWEET CLOVER POLLEN melilotus albus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-114 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELILOTUS ALBUS POLLEN (UNII: 9L67M8B78R) (MELILOTUS ALBUS POLLEN - UNII:9L67M8B78R) MELILOTUS ALBUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-114-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-114-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-114-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-114-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SUGAR BEET POLLEN beta vulgaris pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-115 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA VULGARIS POLLEN (UNII: W7NU4B5CIY) (BETA VULGARIS POLLEN - UNII:W7NU4B5CIY) BETA VULGARIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-115-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-115-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-115-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-115-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WESTERN JUNE GRASS POLLEN koeleria macrantha pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-116 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KOELERIA MACRANTHA POLLEN (UNII: IIC6H3WF6J) (KOELERIA MACRANTHA POLLEN - UNII:IIC6H3WF6J) KOELERIA MACRANTHA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-116-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-116-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-116-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-116-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BROOMWEED POLLEN amphiachyris dracunculoides pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-121 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPHIACHYRIS DRACUNCULOIDES POLLEN (UNII: 83X1I1RR5F) (AMPHIACHYRIS DRACUNCULOIDES POLLEN - UNII:83X1I1RR5F) AMPHIACHYRIS DRACUNCULOIDES POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-121-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-121-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-121-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-121-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

CARELESS WEED POLLEN amaranthus palmeri pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-122 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (AMARANTHUS PALMERI POLLEN - UNII:1GH3WV23KH) AMARANTHUS PALMERI POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-122-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-122-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-122-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-122-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

COCKLEBUR POLLEN xanthium strumarium pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-123 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (XANTHIUM STRUMARIUM POLLEN - UNII:2QOF601J1M) XANTHIUM STRUMARIUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-123-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-123-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-123-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-123-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

YELLOW CURLY DOCK POLLEN rumex crispus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-126 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-126-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-126-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-126-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-126-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

FIREBUSH KOCHIA POLLEN kochia scoparia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-127 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KOCHIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (KOCHIA SCOPARIA POLLEN - UNII:07A108ZKW5) KOCHIA SCOPARIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-127-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-127-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-127-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-127-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GOLDENROD POLLEN solidago canadensis pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-128 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (SOLIDAGO CANADENSIS POLLEN - UNII:644CZ16IR5) SOLIDAGO CANADENSIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-128-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-128-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-128-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-128-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GREASEWOOD POLLEN sarcobatus vermiculatus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-129 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SARCOBATUS VERMICULATUS POLLEN (UNII: 6532U64A3X) (SARCOBATUS VERMICULATUS POLLEN - UNII:6532U64A3X) SARCOBATUS VERMICULATUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-129-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-129-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-129-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-129-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GROUNDSEL TREE POLLEN baccharis halimifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-130 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACCHARIS HALIMIFOLIA POLLEN (UNII: BBO1IJ3ZIW) (BACCHARIS HALIMIFOLIA POLLEN - UNII:BBO1IJ3ZIW) BACCHARIS HALIMIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-130-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-130-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-130-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-130-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

NETTLE POLLEN urtica dioica pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-131 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (URTICA DIOICA POLLEN - UNII:DNB59M1NVU) URTICA DIOICA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-131-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-131-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-131-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-131-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

LAMBS QUARTERS POLLEN chenopodium album pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-132 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (CHENOPODIUM ALBUM POLLEN - UNII:098LKX5NCN) CHENOPODIUM ALBUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-132-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-132-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-132-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-132-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

BURWEED MARSHELDER POLLEN iva xanthifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-133 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (IVA XANTHIFOLIA POLLEN - UNII:V80TPZ0T6J) IVA XANTHIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-133-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-133-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-133-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-133-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

NARROWLEAF MARSHELDER POLLEN iva angustifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-134 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANGUSTIFOLIA POLLEN (UNII: UBW6O1H50I) (IVA ANGUSTIFOLIA POLLEN - UNII:UBW6O1H50I) IVA ANGUSTIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-134-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-134-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-134-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-134-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

COMMON MUGWORT POLLEN artemisia vulgaris pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-136 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (ARTEMISIA VULGARIS POLLEN - UNII:ANT994T71D) ARTEMISIA VULGARIS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-136-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-136-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-136-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-136-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ROUGH MARSHELDER POLLEN iva annua var. annua pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-135 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVA ANNUA VAR. ANNUA POLLEN (UNII: Y2U5S5PF22) (IVA ANNUA VAR. ANNUA POLLEN - UNII:Y2U5S5PF22) IVA ANNUA VAR. ANNUA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-135-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-135-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-135-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-135-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SPINY PIGWEED POLLEN amaranthus spinosus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-137 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-137-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-137-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-137-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-137-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ROUGH REDROOT PIGWEED POLLEN amaranthus retroflexus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-138 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-138-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-138-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-138-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-138-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PIGWEED MIX, ROUGH/SPINY POLLEN amaranthus retroflexus pollen and amaranthus spinosus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-139 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (AMARANTHUS RETROFLEXUS POLLEN - UNII:73B14PX5FW) AMARANTHUS RETROFLEXUS POLLEN 0.5 g in 20 mL AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (AMARANTHUS SPINOSUS POLLEN - UNII:380W4HYR6N) AMARANTHUS SPINOSUS POLLEN 0.5 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-139-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-139-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-139-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-139-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ENGLISH PLANTAIN POLLEN plantago lanceolata pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-140 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (PLANTAGO LANCEOLATA POLLEN - UNII:DO87T1U2CI) PLANTAGO LANCEOLATA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-140-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-140-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-140-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-140-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

FALSE BUR RAGWEED POLLEN ambrosia acanthicarpa pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-145 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (AMBROSIA ACANTHICARPA POLLEN - UNII:U2AI3H2J5Y) AMBROSIA ACANTHICARPA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-145-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-145-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-145-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-145-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

GIANT RAGWEED POLLEN ambrosia trifida pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-146 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-146-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-146-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-146-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-146-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

STANDARDIZED SHORT RAGWEED POLLEN ambrosia artemisiifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-147 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 1 g in 10 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-147-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-147-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-147-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-147-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101387 01/26/1982

WESTERN RAGWEED POLLEN ambrosia psilostachya pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-150 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-150-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-150-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-150-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-150-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

3-RAGWEED MIX, GIANT/SHORT/WESTERN POLLEN ambrosia psilostachya pollen and ambrosia trifida pollen and ambrosia artemisiifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-153 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (AMBROSIA PSILOSTACHYA POLLEN - UNII:RX18M46K8L) AMBROSIA PSILOSTACHYA POLLEN 0.33 g in 20 mL AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (AMBROSIA TRIFIDA POLLEN - UNII:KU1V1898XX) AMBROSIA TRIFIDA POLLEN 0.33 g in 20 mL AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA POLLEN 0.34 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-153-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-153-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-153-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-153-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

RUSSIAN THISTLE POLLEN salsola kali pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-154 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (SALSOLA KALI POLLEN - UNII:2MH135KC6G) SALSOLA KALI POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-154-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-154-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-154-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-154-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

COMMON BIG SAGEBRUSH POLLEN artemisia tridentata pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-155 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-155-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-155-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-155-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-155-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SAGE MIX, COMMON/DARK-LEAVED/DRAGON/PASTURE POLLEN artemisia ludoviciana pollen and artemisia tridentata pollen and artemisia dracunculus pollen and artemisia frigida pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-159 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA LUDOVICIANA POLLEN (UNII: 57KIJ4772H) (ARTEMISIA LUDOVICIANA POLLEN - UNII:57KIJ4772H) ARTEMISIA LUDOVICIANA POLLEN 0.25 g in 20 mL ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (ARTEMISIA TRIDENTATA POLLEN - UNII:YI19RB8YFD) ARTEMISIA TRIDENTATA POLLEN 0.25 g in 20 mL ARTEMISIA DRACUNCULUS POLLEN (UNII: UU78E56M7L) (ARTEMISIA DRACUNCULUS POLLEN - UNII:UU78E56M7L) ARTEMISIA DRACUNCULUS POLLEN 0.25 g in 20 mL ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 0.25 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-159-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-159-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-159-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-159-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

PRAIRIE SAGE POLLEN artemisia frigida pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-158 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA FRIGIDA POLLEN (UNII: 5AN5LR8L3F) (ARTEMISIA FRIGIDA POLLEN - UNII:5AN5LR8L3F) ARTEMISIA FRIGIDA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-158-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-158-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-158-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-158-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ANNUAL SALTBUSH POLLEN atriplex wrightii pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-160 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (ATRIPLEX WRIGHTII POLLEN - UNII:YB1308W43O) ATRIPLEX WRIGHTII POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-160-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-160-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-160-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-160-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SHADSCALE POLLEN atriplex confertifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-161 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CONFERTIFOLIA POLLEN (UNII: GG8WX068MX) (ATRIPLEX CONFERTIFOLIA POLLEN - UNII:GG8WX068MX) ATRIPLEX CONFERTIFOLIA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-161-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-161-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-161-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-161-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

SOUR DOCK SHEEP SORREL POLLEN rumex acetosella pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-162 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (RUMEX ACETOSELLA POLLEN - UNII:N52MIQ81ZW) RUMEX ACETOSELLA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-162-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-162-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-162-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-162-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WATER HEMP POLLEN amaranthus tuberculatus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-163 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (AMARANTHUS TUBERCULATUS POLLEN - UNII:92N6W6KO2G) AMARANTHUS TUBERCULATUS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-163-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-163-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-163-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-163-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

WINGSCALE POLLEN atriplex canescens pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-164 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATRIPLEX CANESCENS POLLEN (UNII: 26U0BU8G83) (ATRIPLEX CANESCENS POLLEN - UNII:26U0BU8G83) ATRIPLEX CANESCENS POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-164-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-164-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-164-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-164-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

ANNUAL WORMWOOD POLLEN artemisia annua pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-166 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA ANNUA POLLEN (UNII: 36R82U4DL6) (ARTEMISIA ANNUA POLLEN - UNII:36R82U4DL6) ARTEMISIA ANNUA POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-166-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-166-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-166-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-166-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

COMMON WORMWOOD POLLEN artemisia absinthium pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-167 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA ABSINTHIUM POLLEN (UNII: 81GS97HVFO) (ARTEMISIA ABSINTHIUM POLLEN - UNII:81GS97HVFO) ARTEMISIA ABSINTHIUM POLLEN 1 g in 20 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.166 g in 100 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.091 g in 100 mL WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-167-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-167-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-167-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-167-50 50 mL in 1 VIAL, MULTI-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA101376 12/07/1967

MEXICAN TEA POLLEN chenopodium ambro