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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 211111


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NDA 211111 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Generics, 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, Zydus Pharms, and Glenmark Pharms Ltd, 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-five suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 211111
Tradename:FLUOCINONIDE
Applicant:Amneal
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211111
Medical Subject Heading (MeSH) Categories for 211111
Suppliers and Packaging for NDA: 211111
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide CREAM;TOPICAL 211111 ANDA Amneal Pharmaceuticals NY LLC 69238-1271 69238-1271-2 1 TUBE in 1 CARTON (69238-1271-2) / 120 g in 1 TUBE
FLUOCINONIDE fluocinonide CREAM;TOPICAL 211111 ANDA Amneal Pharmaceuticals NY LLC 69238-1271 69238-1271-3 1 TUBE in 1 CARTON (69238-1271-3) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Jun 4, 2018TE:ABRLD:No

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