Details for New Drug Application (NDA): 072933
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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 072933
Tradename: | FLUOCINONIDE |
Applicant: | Fougera Pharms Inc |
Ingredient: | fluocinonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 072933
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 072933
Suppliers and Packaging for NDA: 072933
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | GEL;TOPICAL | 072933 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0135 | 0168-0135-15 | 15 g in 1 TUBE (0168-0135-15) |
FLUOCINONIDE | fluocinonide | GEL;TOPICAL | 072933 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0135 | 0168-0135-60 | 60 g in 1 TUBE (0168-0135-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Dec 30, 1994 | TE: | AB | RLD: | No |
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