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 ambrosioides pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-168 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHENOPODIUM AMBROSIOIDES POLLEN (UNII: WIB701MW2H) (CHENOPODIUM AMBROSIOIDES POLLEN - UNII:WIB701MW2H) CHENOPODIUM AMBROSIOIDES 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:54575-168-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-168-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-168-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-168-50 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

DOCK MIX, SOUR SHEEP SORREL/YELLOW POLLEN rumex acetosella pollen and rumex crispus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-169 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 0.5 g in 20 mL RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (RUMEX CRISPUS POLLEN - UNII:V825XJG64G) RUMEX CRISPUS 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:54575-169-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-169-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-169-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-169-50 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 RAGWEED MIX, GIANT/SHORT ambrosia trifida pollen and ambrosia artemisiifolia pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-170 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 0.5 g in 20 mL AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (AMBROSIA ARTEMISIIFOLIA POLLEN - UNII:K20Y81ACO3) AMBROSIA ARTEMISIIFOLIA 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:54575-170-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-170-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-170-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-170-50 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

DANDELION POLLEN taraxacum officinale pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-175 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TARAXACUM OFFICINALE POLLEN (UNII: WQ3S5294XY) (TARAXACUM OFFICINALE POLLEN - UNII:WQ3S5294XY) TARAXACUM OFFICINALE 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:54575-175-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-175-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-175-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-175-50 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

SUNFLOWER POLLEN helianthus annuus pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-179 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELIANTHUS ANNUUS POLLEN (UNII: 28D6K7E9IP) (HELIANTHUS ANNUUS POLLEN - UNII:28D6K7E9IP) HELIANTHUS ANNUUS 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:54575-179-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-179-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-179-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-179-50 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

ALTERNARIA TENUIS ALTERNATA alternaria alternata injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-181 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (UNII: 52B29REC7H) (ALTERNARIA ALTERNATA - UNII:52B29REC7H) ALTERNARIA ALTERNATA 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:54575-181-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-181-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-181-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-181-50 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

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-182 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 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:54575-182-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-182-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-182-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-182-50 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

ASPERGILLUS GLAUCUS eurotium herbariorum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-183 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUROTIUM HERBARIORUM (UNII: 49W168AES4) (EUROTIUM HERBARIORUM - UNII:49W168AES4) EUROTIUM HERBARIORUM 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:54575-183-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-183-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-183-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-183-50 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

ASPERGILLUS NIGER aspergillus niger var. niger injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-184 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS NIGER VAR. NIGER (UNII: 9IOA40ANG6) (ASPERGILLUS NIGER VAR. NIGER - UNII:9IOA40ANG6) ASPERGILLUS NIGER VAR. NIGER 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:54575-184-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-184-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-184-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-184-50 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

ASPERGILLUS TERREUS aspergillus terreus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-185 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS TERREUS (UNII: QBN8K7055X) (ASPERGILLUS TERREUS - UNII:QBN8K7055X) ASPERGILLUS TERREUS 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:54575-185-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-185-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-185-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-185-50 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

PULLULARIA PULLULANS aureobasidium pullulans var. pullutans injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-186 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 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:54575-186-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-186-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-186-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-186-50 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

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-187 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 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:54575-187-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-187-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-187-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-187-50 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

CANDIDA MONILA ALBICANS candida albicans injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-188 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 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:54575-188-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-188-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-188-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-188-50 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

CEPHALOSPORIUM ACREMONIUM acremonium strictum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-189 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACREMONIUM STRICTUM (UNII: 3F36V0451W) (ACREMONIUM STRICTUM - UNII:3F36V0451W) ACREMONIUM STRICTUM 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:54575-189-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-189-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-189-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-189-50 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

CEPHALOTHECIUM ROSEUM trichothecium roseum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-190 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 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:54575-190-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-190-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-190-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-190-50 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

CHAETOMIUM GLOBOSUM chaetomium globosum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-191 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 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:54575-191-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-191-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-191-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-191-50 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

CLADOSPORIUM FULVUM passalora fulva injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-192 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 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:54575-192-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-192-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-192-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-192-50 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

CURVULARIA SPICIFERA cochliobolus spicifer injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-193 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 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:54575-193-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-193-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-193-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-193-50 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

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-194 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 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:54575-194-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-194-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-194-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-194-50 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

EPIDERMOPHYTON FLOCCOSUM epidermophyton floccosum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-195 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPIDERMOPHYTON FLOCCOSUM (UNII: 6JR6JTN25S) (EPIDERMOPHYTON FLOCCOSUM - UNII:6JR6JTN25S) EPIDERMOPHYTON FLOCCOSUM 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:54575-195-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-195-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-195-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-195-50 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

FUSARIUM VASINFECTUM OXYSPORUM fusarium oxysporum vasinfectum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-196 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 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:54575-196-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-196-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-196-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-196-50 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

FUSARIUM SOLANI haematonectria haematococca injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-197 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAEMATONECTRIA HAEMATOCOCCA (UNII: 7TLR512M4A) (HAEMATONECTRIA HAEMATOCOCCA - UNII:7TLR512M4A) HAEMATONECTRIA HAEMATOCOCCA 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:54575-197-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-197-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-197-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-197-50 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

GEOTRICHUM CANDIDUM geotrichum candidum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-199 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 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:54575-199-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-199-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-199-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-199-50 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

HELMINTHOSPORIUM SATIVUM cochliobolus sativus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-201 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 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:54575-201-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-201-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-201-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-201-50 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

HORMODENDRUM CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-202 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (UNII: 4ZWY20GTGO) (CLADOSPORIUM CLADOSPORIOIDES - UNII:4ZWY20GTGO) CLADOSPORIUM CLADOSPORIOIDES 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:54575-202-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-202-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-202-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-202-50 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

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-208 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 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:54575-208-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-208-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-208-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-208-50 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

MUCOR RACEMOSUS mucor racemosus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-209 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR RACEMOSUS (UNII: 17RH99LQ7G) (MUCOR RACEMOSUS - UNII:17RH99LQ7G) MUCOR RACEMOSUS 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:54575-209-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-209-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-209-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-209-50 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

NEUROSPORA SITOPHILA neurospora sitophila injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-211 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEUROSPORA SITOPHILA (UNII: I9D9Z5GCW5) (NEUROSPORA SITOPHILA - UNII:I9D9Z5GCW5) NEUROSPORA SITOPHILA 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:54575-211-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-211-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-211-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-211-50 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

NIGROSPORA SPHAERICA khuskia oryzae injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-212 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 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:54575-212-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-212-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-212-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-212-50 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

PENICILLIUM NOTATUM CHRYSOGENUM penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-214 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 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:54575-214-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-214-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-214-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-214-50 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

PHOMA DESTRUCTIVA phoma destructiva injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-216 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHOMA DESTRUCTIVA (UNII: A17SE577FM) (PHOMA DESTRUCTIVA - UNII:A17SE577FM) PHOMA DESTRUCTIVA 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:54575-216-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-216-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-216-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-216-50 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

RHIZOPUS NIGRICANS rhizopus stolonifer injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-217 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 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:54575-217-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-217-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-217-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-217-50 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

RHODOTORULA MUCILAGINOSA rhodotorula mucilaginosa injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-218 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA MUCILAGINOSA (UNII: 62TY3X4N9Z) (RHODOTORULA MUCILAGINOSA - UNII:62TY3X4N9Z) RHODOTORULA MUCILAGINOSA 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:54575-218-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-218-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-218-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-218-50 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

SPONDYLOCLADIUM ATROVIRENS helminthosporium solani injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-220 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 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:54575-220-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-220-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-220-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-220-50 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

STEMPHYLIUM SARCINIFORME stemphylium sarciniforme injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-222 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STEMPHYLIUM SARCINIFORME (UNII: XQ14H1462M) (STEMPHYLIUM SARCINIFORME - UNII:XQ14H1462M) STEMPHYLIUM SARCINIFORME 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:54575-222-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-222-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-222-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-222-50 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

TRICHODERMA LIGNORUM trichoderma viride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-223 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 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:54575-223-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-223-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-223-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-223-50 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

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-224 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (UNII: 199I7J3JIV) (TRICHOPHYTON MENTAGROPHYTES - UNII:199I7J3JIV) TRICHOPHYTON MENTAGROPHYTES 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:54575-224-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-224-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-224-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-224-50 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

TRICHOPHYTON RUBRUM trichophyton rubrum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-225 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON RUBRUM (UNII: 2ZAU32517N) (TRICHOPHYTON RUBRUM - UNII:2ZAU32517N) TRICHOPHYTON RUBRUM 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:54575-225-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-225-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-225-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-225-50 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

TRICHOPHYTON TONSURANS trichophyton tonsurans injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-226 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON TONSURANS (UNII: JY1BE33I3Y) (TRICHOPHYTON TONSURANS - UNII:JY1BE33I3Y) TRICHOPHYTON TONSURANS 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:54575-226-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-226-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-226-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-226-50 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

VERTICILLIUM ALBO ATRUM verticillium albo-atrum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-227 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 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:54575-227-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-227-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-227-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-227-50 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

BERMUDA GRASS SMUT ustilago cynodontis injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-240 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO CYNODONTIS (UNII: 0V3J4YEX2W) (USTILAGO CYNODONTIS - UNII:0V3J4YEX2W) USTILAGO CYNODONTIS 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:54575-240-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-240-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-240-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-240-50 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

CORN SMUT ustilago maydis injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-241 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS 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:54575-241-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-241-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-241-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-241-50 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 SMUT sporisorium cruentum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-243 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPORISORIUM CRUENTUM (UNII: GQM6LVU5V8) (SPORISORIUM CRUENTUM - UNII:GQM6LVU5V8) SPORISORIUM CRUENTUM 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:54575-243-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-243-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-243-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-243-50 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

WHEAT RUST puccinia graminis injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-248 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PUCCINIA GRAMINIS (UNII: O0HJ02QBWN) (PUCCINIA GRAMINIS - UNII:O0HJ02QBWN) PUCCINIA GRAMINIS 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:54575-248-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-248-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-248-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-248-50 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

COTTON SEED FOR DIAGNOSTIC USE ONLY cotton seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-257 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN) COTTON 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-257-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-257-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-257-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-257-50 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

FLAX SEED FOR DIAGNOSTIC USE ONLY flax seed injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-259 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C) FLAX 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 50 mL in 100 mL

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54575-259-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-259-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-259-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-259-50 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

HOUSE DUST house dust injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-267 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOUSE DUST (UNII: EYO007VX98) (HOUSE DUST - UNII:EYO007VX98) HOUSE DUST 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:54575-267-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-267-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-267-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-267-50 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

KAPOK ceiba pentandra fiber injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-270 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEIBA PENTANDRA FIBER (UNII: 758Z9H9WV9) (CEIBA PENTANDRA FIBER - UNII:758Z9H9WV9) CEIBA PENTANDRA FIBER 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:54575-270-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-270-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-270-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-270-50 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

ORRIS ROOT iris germanica var. florentina root injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-272 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD) (IRIS GERMANICA VAR. FLORENTINA ROOT - UNII:M30XO5X4XD) IRIS GERMANICA VAR. FLORENTINA ROOT 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:54575-272-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-272-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-272-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-272-50 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

PYRETHRUM tanacetum cinerariifolium flower injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-273 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TANACETUM CINERARIIFOLIUM FLOWER (UNII: CGF76TP7X6) (TANACETUM CINERARIIFOLIUM FLOWER - UNII:CGF76TP7X6) TANACETUM CINERARIIFOLIUM FLOWER 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:54575-273-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-273-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-273-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-273-50 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

SILK bombyx mori fiber injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-278 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOMBYX MORI FIBER (UNII: 6LK42KUV6W) (BOMBYX MORI FIBER - UNII:6LK42KUV6W) BOMBYX MORI FIBER 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:54575-278-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-278-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-278-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-278-50 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

COTTON LINTERS cotton fiber injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-284 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COTTON FIBER (UNII: 70LDW53ROO) (COTTON FIBER - UNII:70LDW53ROO) COTTON FIBER 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:54575-284-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-284-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-284-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-284-50 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

CATTLE HAIR AND EPITHELIA bos taurus hair and bos taurus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-289 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOS TAURUS HAIR (UNII: TOQ97Z8644) (BOS TAURUS HAIR - UNII:TOQ97Z8644) BOS TAURUS HAIR 1 g in 20 mL BOS TAURUS SKIN (UNII: 7J12CD6O9L) (BOS TAURUS SKIN - UNII:7J12CD6O9L) BOS TAURUS SKIN 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:54575-289-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-289-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-289-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-289-50 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

DOG HAIR AND EPITHELIA canis lupus familiaris hair and canis lupus familiaris skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-291 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANIS LUPUS FAMILIARIS HAIR (UNII: 05S7L91ZTR) (CANIS LUPUS FAMILIARIS HAIR - UNII:05S7L91ZTR) CANIS LUPUS FAMILIARIS HAIR 1 g in 20 mL CANIS LUPUS FAMILIARIS SKIN (UNII: X2W7CLE97T) (CANIS LUPUS FAMILIARIS SKIN - UNII:X2W7CLE97T) CANIS LUPUS FAMILIARIS SKIN 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:54575-291-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-291-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-291-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-291-50 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

CHICKEN FEATHERS gallus gallus feather injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-293 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 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:54575-293-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-293-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-293-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-293-50 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

DUCK FEATHERS anas platyrhynchos feather injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-294 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 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:54575-294-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-294-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-294-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-294-50 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

GOOSE FEATHERS anser anser feather injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-295 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 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:54575-295-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-295-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-295-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-295-50 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

FEATHER MIX, CHICKEN/DUCK/GOOSE gallus gallus feather and anas platyrhynchos feather and anser anser feather injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-296 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALLUS GALLUS FEATHER (UNII: 1FCM16V0FV) (GALLUS GALLUS FEATHER - UNII:1FCM16V0FV) GALLUS GALLUS FEATHER 0.33 g in 20 mL ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 0.33 g in 20 mL ANSER ANSER FEATHER (UNII: 15XI414745) (ANSER ANSER FEATHER - UNII:15XI414745) ANSER ANSER FEATHER 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:54575-296-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-296-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-296-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-296-50 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

GUINEA PIG HAIR AND EPITHELIA cavia porcellus hair and cavia porcellus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-299 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAVIA PORCELLUS HAIR (UNII: KBA5Y6X57N) (CAVIA PORCELLUS HAIR - UNII:KBA5Y6X57N) CAVIA PORCELLUS HAIR 0.5 g in 20 mL CAVIA PORCELLUS SKIN (UNII: GM3H4U6QS8) (CAVIA PORCELLUS SKIN - UNII:GM3H4U6QS8) CAVIA PORCELLUS SKIN 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:54575-299-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-299-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-299-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-299-50 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

HAMSTER HAIR AND EPITHELIA mesocricetus auratus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-300 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESOCRICETUS AURATUS SKIN (UNII: 3K873H631W) (MESOCRICETUS AURATUS SKIN - UNII:3K873H631W) MESOCRICETUS AURATUS SKIN 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:54575-300-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-300-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-300-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-300-50 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

HOG HAIR AND EPITHELIA sus scrofa hair and sus scrofa skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-301 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA HAIR (UNII: 7Q7T9Z7QUW) (SUS SCROFA HAIR - UNII:7Q7T9Z7QUW) SUS SCROFA HAIR 1 g in 20 mL SUS SCROFA SKIN (UNII: 3EM4VW6TQN) (SUS SCROFA SKIN - UNII:3EM4VW6TQN) SUS SCROFA SKIN 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:54575-301-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-301-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-301-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-301-50 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

HORSE HAIR AND DANDER equus caballus hair and equus caballus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-302 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EQUUS CABALLUS HAIR (UNII: 4F35XG0149) (EQUUS CABALLUS HAIR - UNII:4F35XG0149) EQUUS CABALLUS HAIR 0.5 g in 20 mL EQUUS CABALLUS SKIN (UNII: 88VZV9HGT4) (EQUUS CABALLUS SKIN - UNII:88VZV9HGT4) EQUUS CABALLUS SKIN 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:54575-302-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-302-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-302-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-302-50 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

MOUSE HAIR AND EPITHELIA mus musculus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-305 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUS MUSCULUS SKIN (UNII: 390AN9GB09) (MUS MUSCULUS SKIN - UNII:390AN9GB09) MUS MUSCULUS SKIN 1 g in 50 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:54575-305-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-305-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-305-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-305-50 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

RABBIT HAIR AND EPITHELIA oryctolagus cuniculus hair and oryctolagus cuniculus skin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-306 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORYCTOLAGUS CUNICULUS HAIR (UNII: 09N62XQ70Y) (ORYCTOLAGUS CUNICULUS HAIR - UNII:09N62XQ70Y) ORYCTOLAGUS CUNICULUS HAIR 0.5 g in 20 mL ORYCTOLAGUS CUNICULUS SKIN (UNII: Z91WAU43WC) (ORYCTOLAGUS CUNICULUS SKIN - UNII:Z91WAU43WC) ORYCTOLAGUS CUNICULUS SKIN 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:54575-306-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-306-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-306-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-306-50 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

FIRE ANT solenopsis invicta injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-315 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLENOPSIS INVICTA (UNII: 5O7CR4P444) (SOLENOPSIS INVICTA - UNII:5O7CR4P444) SOLENOPSIS INVICTA 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:54575-315-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-315-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-315-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-315-50 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 COCKROACH periplaneta americana injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-318 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA 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:54575-318-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-318-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-318-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-318-50 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

GERMAN COCKROACH blatella germanica injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-319 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLATELLA GERMANICA (UNII: G9O67I0A8Q) (BLATELLA GERMANICA - UNII:G9O67I0A8Q) BLATELLA GERMANICA 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:54575-319-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-319-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-319-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-319-50 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

HOUSEFLY FOR DIAGNOSTIC USE ONLY musca domestica injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-321 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUSCA DOMESTICA (UNII: PV7823W303) (MUSCA DOMESTICA - UNII:PV7823W303) MUSCA DOMESTICA 1 g in 50 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:54575-321-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-321-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-321-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-321-50 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

MOSQUITO FOR DIAGNOSTIC USE ONLY aedes taeniorhynchus injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-324 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AEDES TAENIORHYNCHUS (UNII: BN2DNW66IQ) (AEDES TAENIORHYNCHUS - UNII:BN2DNW66IQ) AEDES TAENIORHYNCHUS 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:54575-324-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-324-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-324-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-324-50 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

RINKEL MOLD MIX A aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phoma exigua var. exigua and penicillium chrysogenum var. chrysogenum and aureobasidium pullulans var. pullutans and rhizopus stolonifer and rhodotorula mucilaginosa and saccharomyces cerevisiae and geotrichum candidum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-228 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (UNII: X88DF51T48) (ASPERGILLUS FUMIGATUS - UNII:X88DF51T48) ASPERGILLUS FUMIGATUS 0.066 g in 20 mL BOTRYTIS CINEREA (UNII: TBW53313S7) (BOTRYTIS CINEREA - UNII:TBW53313S7) BOTRYTIS CINEREA 0.066 g in 20 mL CHAETOMIUM GLOBOSUM (UNII: 5016WB8B8A) (CHAETOMIUM GLOBOSUM - UNII:5016WB8B8A) CHAETOMIUM GLOBOSUM 0.066 g in 20 mL EPICOCCUM NIGRUM (UNII: 87U156LEN7) (EPICOCCUM NIGRUM - UNII:87U156LEN7) EPICOCCUM NIGRUM 0.066 g in 20 mL FUSARIUM OXYSPORUM VASINFECTUM (UNII: 6M98DC08TZ) (FUSARIUM OXYSPORUM VASINFECTUM - UNII:6M98DC08TZ) FUSARIUM OXYSPORUM VASINFECTUM 0.066 g in 20 mL COCHLIOBOLUS SATIVUS (UNII: 3LN5B70U4W) (COCHLIOBOLUS SATIVUS - UNII:3LN5B70U4W) COCHLIOBOLUS SATIVUS 0.067 g in 20 mL NEUROSPORA SITOPHILA (UNII: I9D9Z5GCW5) (NEUROSPORA SITOPHILA - UNII:I9D9Z5GCW5) NEUROSPORA SITOPHILA 0.067 g in 20 mL MUCOR PLUMBEUS (UNII: D7401PWY6E) (MUCOR PLUMBEUS - UNII:D7401PWY6E) MUCOR PLUMBEUS 0.067 g in 20 mL PHOMA EXIGUA VAR. EXIGUA (UNII: 8JAG41IE4M) (PHOMA EXIGUA VAR. EXIGUA - UNII:8JAG41IE4M) PHOMA EXIGUA VAR. EXIGUA 0.067 g in 20 mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.067 g in 20 mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK) (AUREOBASIDIUM PULLULANS VAR. PULLUTANS - UNII:D1A2NG69CK) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.067 g in 20 mL RHIZOPUS STOLONIFER (UNII: FEE198DK4Q) (RHIZOPUS STOLONIFER - UNII:FEE198DK4Q) RHIZOPUS STOLONIFER 0.067 g in 20 mL RHODOTORULA MUCILAGINOSA (UNII: 62TY3X4N9Z) (RHODOTORULA MUCILAGINOSA - UNII:62TY3X4N9Z) RHODOTORULA MUCILAGINOSA 0.067 g in 20 mL SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE 0.067 g in 20 mL GEOTRICHUM CANDIDUM (UNII: 5964J742O8) (GEOTRICHUM CANDIDUM - UNII:5964J742O8) GEOTRICHUM CANDIDUM 0.067 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:54575-228-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-228-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-228-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-228-50 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

RINKEL MOLD MIX B trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces variotii and microascus brevicaulis and helminthosporium solani and pleospora tarda and streptomyces griseus and trichoderma viride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-229 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOTHECIUM ROSEUM (UNII: TGO054E31O) (TRICHOTHECIUM ROSEUM - UNII:TGO054E31O) TRICHOTHECIUM ROSEUM 0.071 g in 20 mL PASSALORA FULVA (UNII: HR6H5057CO) (PASSALORA FULVA - UNII:HR6H5057CO) PASSALORA FULVA 0.071 g in 20 mL COCHLIOBOLUS SPICIFER (UNII: 91M9RWP3TD) (COCHLIOBOLUS SPICIFER - UNII:91M9RWP3TD) COCHLIOBOLUS SPICIFER 0.071 g in 20 mL MYROTHECIUM VERRUCARIA (UNII: W5U19AK212) (MYROTHECIUM VERRUCARIA - UNII:W5U19AK212) MYROTHECIUM VERRUCARIA 0.071 g in 20 mL TRICHOPHYTON SCHOENLEINII (UNII: Z4MD1809H1) (TRICHOPHYTON SCHOENLEINII - UNII:Z4MD1809H1) TRICHOPHYTON SCHOENLEINII 0.071 g in 20 mL Mycogone nigra (UNII: 0X3XUJ41IX) (Mycogone nigra - UNII:0X3XUJ41IX) Mycogone nigra 0.071 g in 20 mL NEUROSPORA CRASSA (UNII: 1X92VM01YP) (NEUROSPORA CRASSA - UNII:1X92VM01YP) NEUROSPORA CRASSA 0.071 g in 20 mL KHUSKIA ORYZAE (UNII: VK8C112WTS) (KHUSKIA ORYZAE - UNII:VK8C112WTS) KHUSKIA ORYZAE 0.071 g in 20 mL PAECILOMYCES VARIOTII (UNII: KO7V58BY40) (PAECILOMYCES VARIOTII - UNII:KO7V58BY40) PAECILOMYCES VARIOTII 0.072 g in 20 mL MICROASCUS BREVICAULIS (UNII: DHI513VXU7) (MICROASCUS BREVICAULIS - UNII:DHI513VXU7) MICROASCUS BREVICAULIS 0.072 g in 20 mL HELMINTHOSPORIUM SOLANI (UNII: U6Z259H815) (HELMINTHOSPORIUM SOLANI - UNII:U6Z259H815) HELMINTHOSPORIUM SOLANI 0.072 g in 20 mL PLEOSPORA TARDA (UNII: TPL549N9R8) (PLEOSPORA TARDA - UNII:TPL549N9R8) PLEOSPORA TARDA 0.072 g in 20 mL STREPTOMYCES GRISEUS (UNII: G0O5980Z7W) (STREPTOMYCES GRISEUS - UNII:G0O5980Z7W) STREPTOMYCES GRISEUS 0.072 g in 20 mL TRICHODERMA VIRIDE (UNII: T8678F0P0Q) (TRICHODERMA VIRIDE - UNII:T8678F0P0Q) TRICHODERMA VIRIDE 0.072 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:54575-229-10 10 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-229-20 2 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-229-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-229-50 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

RINKEL MOLD MIX C absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum and syncephalastrum racemosum and tetracoccosporium paxianum and verticillium albo-atrum and thermomyces lanuginosus and trichosporon cutaneum injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-230 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Absidia capillata (UNII: 15VX0351MT) (Absidia capillata - UNII:15VX0351MT) Absidia capillata 0.076 g in 20 mL ACROTHECIUM ROBUSTUM (UNII: C91ZMT66YA) (ACROTHECIUM ROBUSTUM - UNII:C91ZMT66YA) ACROTHECIUM ROBUSTUM 0.077 g in 20 mL MICROSPORUM AUDOUINII (UNII: B7B86Y84R8) (MICROSPORUM AUDOUINII - UNII:B7B86Y84R8) MICROSPORUM AUDOUINII 0.077 g in 20 mL MICROSPORUM CANIS (UNII: N4F4RQ7BY7) (MICROSPORUM CANIS - UNII:N4F4RQ7BY7) MICROSPORUM CANIS 0.077 g in 20 mL APIOSPORA MONTAGNEI (UNII: 49VI1ZSO06) (APIOSPORA MONTAGNEI - UNII:49VI1ZSO06) APIOSPORA MONTAGNEI 0.077 g in 20 mL PHYCOMYCES BLAKESLEEANUS (UNII: 41Y752Y34M) (PHYCOMYCES BLAKESLEEANUS - UNII:41Y752Y34M) PHYCOMYCES BLAKESLEEANUS 0.077 g in 20 mL SPOROTRICHUM PRUINOSUM (UNII: H20KU95UBG) (SPOROTRICHUM PRUINOSUM - UNII:H20KU95UBG) SPOROTRICHUM PRUINOSUM 0.077 g in 20 mL STACHYBOTRYS CHARTARUM (UNII: HJ4L70T1ZP) (STACHYBOTRYS CHARTARUM - UNII:HJ4L70T1ZP) STACHYBOTRYS CHARTARUM 0.077 g in 20 mL SYNCEPHALASTRUM RACEMOSUM (UNII: 2VWV12V9WR) (SYNCEPHALASTRUM RACEMOSUM - UNII:2VWV12V9WR) SYNCEPHALASTRUM RACEMOSUM 0.077 g in 20 mL TETRACOCCOSPORIUM PAXIANUM (UNII: KSY1AWN59I) (TETRACOCCOSPORIUM PAXIANUM - UNII:KSY1AWN59I) TETRACOCCOSPORIUM PAXIANUM 0.077 g in 20 mL VERTICILLIUM ALBO-ATRUM (UNII: X92O101CS2) (VERTICILLIUM ALBO-ATRUM - UNII:X92O101CS2) VERTICILLIUM ALBO-ATRUM 0.077 g in 20 mL THERMOMYCES LANUGINOSUS (UNII: YI3WT83KTW) (THERMOMYCES LANUGINOSUS - UNII:YI3WT83KTW) THERMOMYCES LANUGINOSUS 0.077 g in 20 mL Trichosporon cutaneum (UNII: 5EUI19VT92) (Trichosporon cutaneum - UNII:5EUI19VT92) Trichosporon cutaneum 0.077 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:54575-230-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-230-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-230-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-230-50 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

OSAGE ORANGE VAR BOIS DARC POLLEN maclura pomifera pollen injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-958 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MACLURA POMIFERA POLLEN (UNII: 18JOK51CZH) (MACLURA POMIFERA POLLEN - UNII:18JOK51CZH) MACLURA POMIFERA 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:54575-958-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-958-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-958-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-958-50 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

LAKE TROUT trout injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-467 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TROUT (UNII: 7TI7U5PF2U) (TROUT - UNII:7TI7U5PF2U) TROUT 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:54575-467-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-467-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-467-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-467-50 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

TUNA tuna injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-468 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TUNA (UNII: V2T3IHT3E2) (TUNA - UNII:V2T3IHT3E2) TUNA 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:54575-468-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-468-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-468-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-468-50 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

TURKEY FOOD turkey injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-469 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TURKEY (UNII: 8E9NT44R8I) (TURKEY - UNII:8E9NT44R8I) TURKEY 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:54575-469-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-469-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-469-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-469-50 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 WALNUT FOOD black walnut injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54575-472 Route of Administration PERCUTANEOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BLACK WALNUT (UNII: 02WM57RXZJ) (BLACK WALNUT - UNII:02WM57RXZJ) BLACK 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:54575-472-02 2 mL in 1 VIAL, MULTI-DOSE 2 NDC:54575-472-10 10 mL in 1 VIAL, MULTI-DOSE 3 NDC:54575-472-30 30 mL in 1 VIAL, MULTI-DOSE 4 NDC:54575-472-50 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

Labeler - Allergy Laboratories, Inc. (007191810)

Establishment
Name	Address	ID/FEI	Business Operations
Allergy Laboratories, Inc.		007191810	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 3/2011 Document Id: dbe7bebd-e445-4e59-8302-e706b795fbde 34391-3 Set id: c1114779-3e11-47ab-8889-f534406f4041 Version: 5 Effective Time: 20110311 Allergy Laboratories, Inc.