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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 209118


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NDA 209118 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-nine 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-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 209118
Tradename:FLUOCINONIDE
Applicant:Chartwell Rx
Ingredient:fluocinonide
Patents:0
Pharmacology for NDA: 209118
Medical Subject Heading (MeSH) Categories for 209118
Suppliers and Packaging for NDA: 209118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 209118 ANDA Glasshouse Pharmaceuticals Limited Canada 71428-001 71428-001-60 1 BOTTLE in 1 CARTON (71428-001-60) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Apr 23, 2018TE:ATRLD:No

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