Details for New Drug Application (NDA): 073085
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The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 073085
Tradename: | FLUOCINONIDE |
Applicant: | Cosette |
Ingredient: | fluocinonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 073085
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 073085
Suppliers and Packaging for NDA: 073085
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 073085 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0663 | 0713-0663-15 | 1 TUBE in 1 CARTON (0713-0663-15) / 15 g in 1 TUBE |
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 073085 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0663 | 0713-0663-31 | 1 TUBE in 1 CARTON (0713-0663-31) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Feb 14, 1992 | TE: | AB1 | RLD: | No |
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