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 Set id: c1114779-3e11-47ab-8889-f534406f4041 Version: 5 Effective Time: 20110311 Allergy Laboratories, Inc.
No Title 1572449452 ⮝
Allergenic Extracts
Directions for Use
Warnings ⮝
See boxed WARNINGS at the beginning of this information sheet.
Do not administer allergenic extract injections intravenously. Patients should always be observed for at least 20 to 30 minutes after any skin test or injection. Concentrated allergenic extracts should be diluted with Sterile Diluent for Allergenic Extract prior to use for intradermal testing and for immunotherapy preparation. Systemic reactions may occur infrequently and may range from mild exaggeration of the patient s allergic symptoms to urticaria, rhinitis, conjunctivitis, angioedema, cough, wheezing, fainting, pallor, bradycardia, hypotension, or even, in extremely sensitive individuals, to anaphylactic shock and death. Have epinephrine 1:1,000 readily available in case of a reaction. Emergency measures and personnel trained for medical emergencies should be immediately available in the event of a life-threatening reaction. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. Patients taking beta-blocker medication may not respond to the usual dose of epinephrine.
Diagnostic testing as well as immunotherapy should be temporarily withheld from patients or the dose reduced until cause of reaction is evaluated by prescribing physician if any of the following conditions exist: (1) severe symptoms of rhinitis and/or asthma, (2) infection or flu accompanied by fever, (3) exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection, and (4) systemic reaction to previous injection.
Description ⮝
Therapeutic extracts (concentrates) are designed primarily for the physician equipped to prepare dilutions and mixtures as necessary. Allergenic Extracts are manufactured from various biological allergenic source materials including pollens, molds, epidermals, insects, food and environmental inhalants. The extraction is performed in a glycerin solution and the resulting concentration is expressed as weight to volume (w/v) ratio. This is the weight of dry pollen in grams to volume of glycerin extracting solution in milliliters. Extracts are filtered and sterile filled. Tests include those for safety and sterility. The route of administration is subcutaneous. Scratch diagnostic extracts are of the same therapeutic extract formulation and their route of administration is percutaneous. Intradermal diagnostic extracts are dilutions of the therapeutic extracts using Sterile Diluent for Allergenic Extract.
Inactive ingredients: Therapeutic and Scratch extracts: Intradermal 1:500 v/v (foods) Intradermal 1:1,000 v/v (pollens, molds, epidermals, inhalants) Glycerin, USP, 50% v/v Glycerin, USP, 0.1% v/v Glycerin, USP, 0.05% v/v Sodium chloride, USP, 0.166% w/v Sodium chloride, USP, 0.9% w/v Sodium chloride, USP, 0.9% w/v Sodium bicarbonate, USP, 0.091% w/v Sodium bicarbonate, USP, 0.000182% w/v Sodium bicarbonate, USP, 0.000091% w/v Phenol, USP, 0.4% w/v Phenol, USP, 0.4% w/v Sterile Diluent for Allergenic Extract: Normal Saline with Phenol: Human Serum Albumin: Glycerin, USP, 50% w/v Sodium chloride, USP 0.9% w/v Sodium chloride, USP 0.9% w/v Sodium bicarbonate, USP 0.091% w/v Phenol, USP 0.4% w/v Phenol, USP 0.4% w/v Sodium chloride, USP 0.166% w/v Water for Injection, USP q.s. Normal Serum Albumin (Human), 0.03% w/v Water for Injection, USP, q.s. Air replaced with Nitrogen, NF Water for Injection, USP q.s. Air replaced with Nitrogen, NF The following allergenic extracts are designated and labeled FOR DIAGNOSTIC USE ONLY . Data to support the therapeutic use of these extracts has not been established: Coffee Cottonseed Flaxseed Housefly Mosquito
The strength of Standardized Short Ragweed and Ragweed Mix, Giant and Short extracts is described (in addition to w/v) as antigen E content. The concentration of antigen E per milliliter of the final preparation as determined by radial immunodiffusion (RID). The antigen E content of an extract is influenced by several variables. These include antigen E content of the pollen, nature of extracting solutions, ratio of pollen weight to volume of extracting solution and storage conditions. Variables which influence antigen E stability during storage conditions include nature of the solvent, antigen E concentration and storage temperature. Glycerin is a stabilizer of antigen E and other allergens.
Clinical Pharmacology ⮝
Allergenic extracts for diagnostic testing produce erythema or erythema and wheal reactions in patients with significant IgE-mediated sensitivity to the relevant allergen. This allergic inflammatory response, although not completely understood, is thought to begin with the reaction of antigen with IgE on the surface of basofils, or mast cells, which initiates a series of biochemical events resulting in the production of histamine and other mediators. These, in turn, produce the immediate-type wheal and flare skin reaction. The more mediator released, the larger the reaction. Because of a variety of factors, including the types of allergen extracts, delayed skin reactions can occur and usually disappear within a couple of days. The type of extract, size of the reaction and timing of the reaction are all factors used in determining a patient s sensitivity to an allergen.
Allergen immunotherapy (also known as desensitization, hyposensitization, allergy vaccination, or allergy shots) involves treating a patient with increasing dosage of the allergens to which he is allergic, eventually reaching a dose plateau whereas the patient experiences an increased tolerance upon re-exposure to the allergens. The patient may or may not need to receive continued treatment to demonstrate the desensitization. The exact mechanisms of reaction of desensitization with allergens, which involve the allergen, IgE and IgG antibodies, mast cells and basophils and possibly other mediators, are not completely understood. However, efficacy has been shown in numerous well-controlled studies using specific common allergens.
The goals of allergen immunotherapy are to decrease the production of IgE antibodies, initiate the production of IgG antibodies and stabilize mast cells and basophils. Overproduction of IgE in response to an allergen can induce other cells, particularly mast cells and basophils, to initiate a complex chain reaction that results in allergy symptoms. Numerous IgE receptor sites are located on mast cells as well as basophil cells. These cells are among the first cells to be encountered by the antigen. They contain potent chemical mediators (histamine and leukotriene, for example) of inflammation that are released when IgE and a specific allergen cross-link on the cell surface. The release of the chemical mediators results in inflammation and allergy symptoms. As a response to immunotherapy, the production of IgG is believed to work by blocking IgE from binding to mast cells and basophils. Thus IgG, the blocking antibody, may prevent the release of chemical mediators that produce allergy symptoms.
Indications And Usage ⮝
Immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. Immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. Treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. It is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.
Contraindications ⮝
There are no known absolute contraindications to diagnostic testing or hyposensitization with allergen immunotherapy.
Patients with cardiovascular disease or pulmonary disease such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal anaphylaxis treatment regimen.
Immunotherapy is not generally indicated when the offending allergen(s) can be effectively eliminated or minimized by environmental control. There are differences of opinion on the possibility of routine immunizations exacerbating autoimmune diseases. The evidence has been inconclusive. Therefore, caution should be exercised in administering immunotherapy to patients with other immunologic diseases and only administered if the risk from exposure to the allergen is greater than the risk of exacerbating the underlying disorder. Injections should be avoided in patients with a bleeding tendency.
Precautions ⮝
(1) GENERAL
The presence of asthmatic signs and symptoms may be an indicator of severe reaction following allergen injections. Any evidence of a local or generalized reaction requires a dose reduction during the initial stages of immunotherapy, as well as during maintenance therapy. Patient reactions to previous injections should be reviewed before each new injection and a conservative dosage schedule should be followed until a pattern of local responses is established which can be used to monitor increases in dosage. Patients should be observed in the office for at least 20 to 30 minutes after each treatment injection and instructed to seek medical attention if symptoms of a systemic reaction occur. Most severe reactions will occur within this time period, and rapid treatment measures should be initiated (see ADVERSE REACTIONS). In rare circumstances, a patient may have systemic reactions to minute doses of antigen and does not demonstrate increasing tolerance to injections after several months of treatment. If systemic reactions or excessive local responses occur persistently at very small doses, efforts at immunotherapy should be stopped.
When changing lots of extracts, even though the formulation may be the same, the first dose should not exceed 50% of the previous dose as the extract may have lost potency over time and a fresh extract could have an effective potency that is substantially greater than that of the old extract. Aseptic technique should always be used when injections of allergenic extracts are administered.
(2) INFORMATION FOR PATIENTS
Patients should be instructed to remain in the office for 20 to 30 minutes after each injection to monitor for adverse reactions. Patients should be instructed to describe any active allergic symptoms such as rhinitis, wheezing, dyspnea, etc. prior to injection including any late reactions from previous administration.
(3) DRUG INTERACTIONS
Beta-Blockers: Patients who are taking non-selective beta blockers may be more reactive to allergens given for testing and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those who are receiving cardiovascular drugs such as beta-blockers, may be at higher risk for severe adverse reactions.
Antihistamines can significantly inhibit the immediate skin test reactions. If long acting antihistamines have been taken recently, it is recommended that they should be stopped for the following minimum intervals before skin testing is performed: 1 week for hydroxyzine or cetirizine; 4 to 7 days for loratadine; 3 to 4 days for fexofenadine; and 24 to 48 hours for other sustained release antihistamines.
(4) CARCINOGENISIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
Long term studies with allergenic extracts have not been conducted in animals to determine their potential for carcinogenesis, mutagenesis, or impairment of fertility.
(5) PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with allergenic extracts. It is also not known whether allergenic extracts can cause fetal harm when administered to a pregnant woman or if they can affect reproduction capacity. The physician must weigh the benefits of immunotherapy against the risk of anaphylactic reactions that could result in harm to the mother and/or fetus. Hyposensitization should be used during pregnancy only if clearly necessary and administered cautiously.
(6) NURSING MOTHERS
It is not known if allergenic extracts appear in human milk. Because many drugs are excreted in human milk, caution should be exercised when allergenic extracts are administered to a nursing woman.
(7) PEDIATRIC USE
Extracts have not been studied in children, so the safety in children has not been established. Doses of allergenic extracts for children are generally the same as those for adults. In the case of large doses, the amount of extract given to a child may be modified so that the discomfort of the injection is minimized.
Adverse Reactions ⮝
(1) Local Reactions - A mild burning immediately after the injection is to be expected; this usually subsides in 10 to 20 seconds. Reactions at the site of injection (erythema, swelling, pruritus) may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence; but if very large, may be the first manifestation of a systemic reaction. Delayed reactions start several hours after injection with local edema, erythema, itching or pain. The reactions are most apparent 24 hours after injection and usually require no treatment. Antihistamines may be administered orally if necessary. Large local reactions may be treated by local applications of cold, wet dressings and/or the use of oral antihistamines. These reactions should be considered a warning of possible severe systemic reaction and need for temporarily reduced dosage. In such cases the next therapeutic dose should be reduced to the last dose which did not elicit a reaction and subsequent doses increased more slowly.
(2) Systemic Reactions - Most severe systemic reactions occur within 30 minutes of injection but may occur at anytime subsequent to treatment. Symptoms may range from mild to life-threatening (due to anaphylaxis). Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, cough, hypotension, syncope and upper airway obstruction. Symptoms may progress to anaphylactic shock and death.
If a systemic or anaphylactic reaction does occur, apply a tourniquet above the site of injection and inject 1:1,000 epinephrine-hydrochloride intramuscularly into the opposite arm or gluteal area. Loosen the tourniquet at least every 10 minutes. Do not obstruct arterial blood flow with the tourniquet.
1:1,000 EPHEDRINE DOSAGE:
ADULT: 0.3 mL to 0.5 mL should be injected intramuscularly or subcutaneously. Repeat in 5 to 10 minutes if necessary.
PEDIATRIC: Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL.
Doses may be repeated every 20 minutes, depending on the severity of the condition and the response of the patient. After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and vasoactive drugs if necessary. An open airway should be insured. Give oxygen by mask. Intravenous antihistamine, inhaled bronchodilators, theophyllin and/or adrenal corticosteroids may be used if necessary after adequate epinephrine and circulatory support has been given. Emergency resuscitation measures and personnel trained in their use must be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures.
If the patient is continued on immunotherapy, a decrease of at least 50% in the next dose should follow serious systemic reactions. Increases in dose should be made cautiously. Repeated systemic reactions are sufficient reason for discontinuation of increased dosages.
(3) To report suspected ADVERSE REACTIONS, contact Allergy Laboratories, Inc. 800-654-3971 or FDA 800-FDA-1088 or www.fda/gov/medwatch.
Overdosage ⮝
Signs and symptoms of overdose are typically local and systemic reactions. For a description and management of overdose reactions, see ADVERSE REACTIONS.
Dosage And Administration ⮝
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Allergenic extracts may be administered for diagnostic testing or therapeutic purposes. The dosage will depend on the particular use of the extract.
General: When used for diagnostic testing to determine a patient s sensitivity to specific antigens and aid in the diagnosis and treatment of atopic disease, the recommended procedure is to initially perform puncture tests, then follow with intradermal tests. The number of skin tests applied at one time will depend on the particular patient and their allergic history. These tests should be performed and observed in 15 to 20 minutes. Additional tests may be applied in sequence. Perform tests on the anterolateral aspect of the upper arm on an area that permits the effective application of a tourniquet proximal to the site of the test. The skin at the site of injection should be disinfected with rubbing alcohol before testing. A positive reaction usually develops in 15 to 20 minutes. The positive response is a wheal and flare reaction that is larger than the negative control and evaluated based on the size of the reaction.
Controls: A negative control containing the same solution that the extract was prepared in should be applied to a test site in the same manner as the tests being performed. Histamine phosphate should be used as a positive control for evaluation of skin testing. Refer to manufacturers directions provided with Histamine phosphate for recommended dosage and administration.
Percutaneous testing: In general, skin is scratched, punctured or pricked just before the allergen is applied or through a drop of test allergen which is placed on the skin. There are several devices available for this technique. Refer to the device manufacturers instructions for proper use. Test areas should be no closer than 4-5 cm apart to avoid the interference of multiple reactions. Clean test areas with alcohol and air dry. Place the allergen on the volar surface of the patient s forearm, upper arm, or back.
1. For puncture tests, apply one drop of extract to the skin. Pierce the drop of extract and skin using a sterile hypodermic needle or vaccinating needle. Maintain the needle perpendicular to the skin surface and rock the needle back and forth to produce a small hole without bleeding. Do not rotate or gouge the needle. Remove needle from skin and wipe excess extract from skin surface.
2. For scratch tests using a scarifier or needle: make a scratch 1/16 inch long on the epidermis penetrating the outer cornified area but being careful not to draw blood. Apply one drop of allergen to the scratch or puncture.
Intracutaneous (Intradermal) testing: If puncture test is negative, proceed with intradermal test. Intradermal tests should not be performed if puncture test is positive. Use a separate sterile syringe (tuberculin type equipped with a 27 gauge by 3/8 inch needle with intradermal bevel) for each antigen. To administer the test, inject 0.02 mL of allergen into the epidermis using dilutions of the concentrated extract; a 1:500 v/v dilution for foods and 1:1,000 v/v dilution for other extracts. If the test has been performed properly, the solution should raise a bleb 2 to 3 mm in diameter. If the bleb does not appear, the injection was made too deeply. To prepare intradermal testing strengths using 1:20 w/v bulk concentrates, use the following example: Add 1 mL of 1:20 w/v to 4 mL diluent to make a 1:100 v/v dilution. Add 1 mL of 1:100 v/v to 4 mL diluent to make a 1:500 v/v dilution. Add 0.5 mL of 1:100 v/v dilution to 4.5 mL diluent to make a 1:1,000 v/v dilution.
Interpretation of results: Percutaneous tests Intradermal tests 1 1+ Erythema with 5mm wheal 0 <5mm Erythema with a <5mm wheal 2+ Erythema with a 5-10mm wheal +/- 5-10mm Erythema with a 5-10mm wheal 3+ Erythema with a 10-15mm wheal 1+ 11-20mm Erythema with a 5-10mm wheal 4+ Erythema with a wheal 15mm or larger with pseudopodia 2+ 21-30mm Erythema with a 5-10mm wheal 3+ 31-40mm Erythema with a 10-15mm wheal or with pseudopodia 4+ >40mm Erythema with >15mm wheal or with pseudopodia Immunotherapy:
(1) General: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Injections are given subcutaneously; preferably in the arm. It is advantageous to give injections in alternate arms. Use sterile precautions and a tuberculin syringe when administering each dose. Allergen immunotherapy is typically initiated with a diluted formulation of allergens prescribed by a physician for administration to a patient. Doses are gradually increased over time and ultimately reach a maintenance dose where the patient is maintained for as long as the physician or patient feels is necessary. The formulation and dosage schedule is determined by the physician and is based on diagnostic testing and patient history. Patients with very high sensitivities should be initiated with lower concentrations (higher dilutions) and may need a very relaxed progression to maintenance doses. Pre-seasonal therapy may be initiated three months before seasonal difficulty begins and brought to maintenance dose and discontinued after that season ends. Perennial therapy (recommended) brings the patient up to tolerated maintenance dose where they remain until improvement of allergic symptoms occurs. Injections may be given at intervals of 4 to 7 days with either therapy.
(2) Suggested dilution series: Concentrated Allergenic Extracts must be diluted with Sterile Diluent for Allergenic Extract before using for immunotherapy. A 1:100,000 v/v dilution of concentrate is usually satisfactory to start treatment. To prepare a 10-fold dilution series from concentrated bulk extract, the following is suggested: Add 1 mL of 1:20 w/v extract to 4 mL diluent to make a 1:100 v/v dilution. Add 0.5 mL of the 1:100 dilution to 4.5 mL of diluent to make a 1:1,000 v/v dilution. Add 0.5 mL of the 1:1,1000 dilution to 4.5 mL diluent to make a 1:10,000 v/v dilution. Add 0.5 mL of the 1:10,000 dilution to 4.5 mL of diluent to make a 1:100,000 v/v dilution. The series may be extended to 1:1,000,000 v/v by preparing one more similar dilution as a precaution for sensitive patients.
(3) Maintenance: The maintenance level is the largest dose tolerated by the patient that relieves symptoms without producing undesirable local or general reactions. After immunotherapy has been established, a maintenance dose should be given at weekly intervals. The interval between maintenance doses can be increased gradually from one week to 10 days, to 2 weeks, 3 weeks, or even 4 weeks as allergy symptoms allow. Repeat maintenance doses at a given interval three or four times to check for continued allergy symptom relief before increasing the interval further. If large local (or systemic) reactions occur at one interval, do not increase the interval. Protection is lost rapidly if the interval between doses is more than 4 weeks. It may not be possible for all patients to reach the maximum dose indicated on the suggested dosage schedule.
(4) Suggested dosage schedule: Because the degree of sensitivity varies in many individuals, the dose and interval may need adjustment and should reflect the patient s tolerance and response. A dose should never be given until all reactions resulting from a previous dose have entirely disappeared. After a period on immunotherapy, better tolerance may permit a longer interval between injections, or a larger maintenance dose, or both.
1:100,000 v/v 1:10,000 v/v 1:1,000 v/v 1:100 v/v Dose Vol. (mL) Dose Vol. (mL) Dose Vol. (mL) Dose Vol. (mL) Maintenance 1 0.02 8 0.02 13 0.02 19 0.02 2 0.04 9 0.05 14 0.05 20 0.05 Continue 0.25 mL of 1:100 v/v weekly. 3 0.06 10 0.10 15 0.10 21 0.08 4 0.10 11 0.15 16 0.15 22 0.10 5 0.15 12 0.25 17 0.20 23 0.15 6 0.20 18 0.25 24 0.20 7 0.25 25 0.25
(5) Dose adjustments: Since the individual components of the extract are those to which the patient is allergic and to which he will be exposed, typical allergic symptoms may follow shortly after the injection, particularly those experienced by the patient during exposure when the antigen from the environment plus the injected antigen exceeds the patient s tolerance to the antigen. In such cases, decrease the size of the next scheduled dose by at least one-half of the previous dose.
(6) Administration: Use aseptic precautions when diluting and/or preparing an injection. To avoid cross-contamination, do not use the same needle to withdraw materials from multiple vials. Use a sterile tuberculin syringe (26 or 27 gauge) with a needle at least 5/8 long and graduated in 0.01 mL units to measure each dose.
How Supplied ⮝
Bulk extract (stock concentrate) in 50% v/v glycerin is supplied in 10 mL, 30 mL, and 50 mL multiple dose vials as well as 2 mL scratch (dropper) vials. Intradermal tests are supplied in 5 mL vials at 1:500 v/v for food extracts and at 1:1,000 v/v for other extracts.
Storage ⮝
To insure the maximum potency of bulk extract and extract dilutions, it is recommended that they be maintained at a temperature of 2 to 8 degrees Celsius. Do not freeze. Do not use after the expiration date shown on the vial label.
References ⮝
- Norman, P.S.: In vivo methods of study of allergy: Skin and Mucosal tests, techniques, and interpretation. In Middleton, E. Jr., Reed, C. E. and Ellis, E.F. (ed): Allergy Principles and Practice, (Vol. 1), p. 258. St. Louis, The C.V. Mosby Co. 1978.
ALLERGY LABORATORIES, INC.
U.S. License # 103
Oklahoma City, OK 73109
(800) 654-3971, (405) 235-1451Rev. 12/2010