Details for New Drug Application (NDA): 008975
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NDA 008975 describes PURIFIED CORTROPHIN GEL, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PURIFIED CORTROPHIN GEL profile page.
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.
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: | 2 |
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 | |||||
| Patent: | 12,102,662 | Patent Expiration: | Oct 27, 2043 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE EXACERBATIONS OF MULTIPLE SCLEROSIS | ||||||||
| Patent: | 12,102,662 | Patent Expiration: | Oct 27, 2043 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ALLERGIC CONJUNCTIVITIS | ||||||||
| Patent: | 12,102,662 | Patent Expiration: | Oct 27, 2043 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ANTERIOR SEGMENT INFLAMMATION | ||||||||
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