Details for New Drug Application (NDA): 077236
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NDA 077236 describes PREDNICARBATE, which is a drug marketed by Fougera Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the PREDNICARBATE profile page.
The generic ingredient in PREDNICARBATE is prednicarbate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prednicarbate profile page.
The generic ingredient in PREDNICARBATE is prednicarbate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prednicarbate profile page.
Summary for 077236
| Tradename: | PREDNICARBATE |
| Applicant: | Fougera Pharms |
| Ingredient: | prednicarbate |
| Patents: | 0 |
Pharmacology for NDA: 077236
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 077236
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREDNICARBATE | prednicarbate | OINTMENT;TOPICAL | 077236 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0410 | 0168-0410-60 | 60 g in 1 TUBE (0168-0410-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Mar 9, 2007 | TE: | RLD: | No | |||||
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