Details for New Drug Application (NDA): 008975
✉ Email this page to a colleague
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 five 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: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 008975
Generic Entry Date for 008975*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INJECTION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 008975
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 | ||||||||
Complete Access Available with Subscription
