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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200735

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NDA 200735 describes FLUOCINONIDE, which is a drug marketed by Acp Nimble, Amneal Pharms Llc, Fougera Pharms Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teligent Pharma Inc, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, Encube Ethicals, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, Zydus Pharms, Glenmark Pharms Ltd, and Taro Pharm Inds Ltd, and is included in forty-two NDAs. It is available from thirty-six 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-seven suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 200735
Applicant:Fougera Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 200735
Medical Subject Heading (MeSH) Categories for 200735
Suppliers and Packaging for NDA: 200735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide CREAM;TOPICAL 200735 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0457 0168-0457-04 1 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE
FLUOCINONIDE fluocinonide CREAM;TOPICAL 200735 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0457 0168-0457-30 1 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Jul 14, 2014TE:ABRLD:No

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