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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 019117


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NDA 019117 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-three 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
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:DISCNDosage:CREAM;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 26, 1984TE:RLD:Yes

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