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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200735

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NDA 200735 describes FLUOCINONIDE, which is a drug marketed by Fougera Pharms Inc, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Perrigo New York, Taro, Teva, Cnty Line Pharms, Fougera Pharms, Novel Labs Inc, and Teva Pharms, and is included in twenty-nine NDAs. It is available from twenty-two suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinonide. There are nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 200735
Tradename:FLUOCINONIDE
Applicant:Fougera Pharms Inc
Ingredient:fluocinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 N 0168-0457-60
FLUOCINONIDE fluocinonide CREAM;TOPICAL 200735 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0457 N 0168-0457-30

Profile for product number 001

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

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