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Serving leading biopharmaceutical companies globally:

Colorcon
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Federal Trade Commission
Fuji
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071535

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NDA 071535 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, Fougera, and Teva Pharms, and is included in twenty-nine NDAs. It is available from twenty-eight 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-two suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 071535
Tradename:FLUOCINONIDE
Applicant:G And W Labs Inc
Ingredient:fluocinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 071535
Medical Subject Heading (MeSH) Categories for 071535
Suppliers and Packaging for NDA: 071535
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide SOLUTION;TOPICAL 071535 ANDA Actavis Pharma, Inc. 0472-0829 0472-0829-02 1 BOTTLE in 1 CARTON (0472-0829-02) > 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Dec 2, 1988TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Healthtrust
Queensland Health
Fish and Richardson
Cipla
AstraZeneca
Dow
Federal Trade Commission

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