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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017373


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NDA 017373 describes FLUOCINONIDE, which is a drug marketed by Acp Nimble, Amneal Pharms Llc, Cadila, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent Pharma Inc, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, Xiromed, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, Zydus Pharms, Glenmark Pharms Ltd, and Taro Pharm Inds Ltd, and is included in forty-four NDAs. It is available from thirty-four 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 017373
Tradename:FLUOCINONIDE
Applicant:Cnty Line Pharms
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017373
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
FLUOCINONIDE fluocinonide GEL;TOPICAL 017373 NDA Alvogen Inc. 47781-533 47781-533-72 1 TUBE in 1 CARTON (47781-533-72) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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