Details for New Drug Application (NDA): 019117
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The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 019117
Tradename: | FLUOCINONIDE |
Applicant: | Taro |
Ingredient: | fluocinonide |
Patents: | 0 |
Pharmacology for NDA: 019117
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019117
Suppliers and Packaging for NDA: 019117
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 019117 | NDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253 | 51672-1253-1 | 1 TUBE in 1 CARTON (51672-1253-1) / 15 g in 1 TUBE |
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 019117 | NDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-1253 | 51672-1253-2 | 1 TUBE in 1 CARTON (51672-1253-2) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 26, 1984 | TE: | RLD: | Yes |
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