Details for New Drug Application (NDA): 074204
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NDA 074204 describes FLUOCINONIDE EMULSIFIED BASE, which is a drug marketed by Cosette, Fougera Pharms, Taro, and Teva, and is included in four NDAs. It is available from three suppliers. Additional details are available on the FLUOCINONIDE EMULSIFIED BASE profile page.
The generic ingredient in FLUOCINONIDE EMULSIFIED BASE is fluocinonide. There are nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
The generic ingredient in FLUOCINONIDE EMULSIFIED BASE is fluocinonide. There are nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 074204
| Tradename: | FLUOCINONIDE EMULSIFIED BASE |
| Applicant: | Cosette |
| Ingredient: | fluocinonide |
| Patents: | 0 |
Pharmacology for NDA: 074204
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 074204
Suppliers and Packaging for NDA: 074204
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE EMULSIFIED BASE | fluocinonide | CREAM;TOPICAL | 074204 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0664 | 0713-0664-15 | 1 TUBE in 1 CARTON (0713-0664-15) / 15 g in 1 TUBE |
| FLUOCINONIDE EMULSIFIED BASE | fluocinonide | CREAM;TOPICAL | 074204 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0664 | 0713-0664-31 | 1 TUBE in 1 CARTON (0713-0664-31) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jun 13, 1995 | TE: | AB2 | RLD: | No | ||||
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