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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Cipla
Fish and Richardson
Teva
Chinese Patent Office
McKesson
McKinsey
Harvard Business School

Generated: June 18, 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 Amneal Pharms Llc, 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, Glasshouse Pharms, Macleods Pharms Ltd, Teva Pharms, and Taro Pharm Inds Ltd, and is included in thirty-two NDAs. It is available from twenty-nine 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. Thirty-three 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 0168-0457-04
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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Cerilliant
Julphar
Healthtrust
Covington
Daiichi Sankyo
Merck
Medtronic

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