Details for New Drug Application (NDA): 017373
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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 017373
Tradename: | FLUOCINONIDE |
Applicant: | Alvogen |
Ingredient: | fluocinonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 017373
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 017373
Suppliers and Packaging for NDA: 017373
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | GEL;TOPICAL | 017373 | NDA | Alvogen Inc. | 47781-533 | 47781-533-26 | 1 TUBE in 1 CARTON (47781-533-26) / 60 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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