Details for New Drug Application (NDA): 008975
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The generic ingredient in PURIFIED CORTROPHIN GEL is corticotropin. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
Summary for 008975
Tradename: | PURIFIED CORTROPHIN GEL |
Applicant: | Ani Pharms |
Ingredient: | corticotropin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 008975
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PURIFIED CORTROPHIN GEL | corticotropin | INJECTABLE;INJECTION | 008975 | NDA | ANI Pharmaceuticals, Inc. | 62559-860 | 62559-860-11 | 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-11) / 1 mL in 1 VIAL, MULTI-DOSE |
PURIFIED CORTROPHIN GEL | corticotropin | INJECTABLE;INJECTION | 008975 | NDA | ANI Pharmaceuticals, Inc. | 62559-860 | 62559-860-15 | 1 VIAL, MULTI-DOSE in 1 CARTON (62559-860-15) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 40 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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