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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071500

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NDA 071500 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, Glasshouse Pharms, Macleods Pharms Ltd, and Teva Pharms, and is included in thirty-one 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 071500
Tradename:FLUOCINONIDE
Applicant:Taro
Ingredient:fluocinonide
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 071500
Medical Subject Heading (MeSH) Categories for 071500
Suppliers and Packaging for NDA: 071500
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE fluocinonide CREAM;TOPICAL 071500 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-1386 N 51672-1386-1
FLUOCINONIDE fluocinonide CREAM;TOPICAL 071500 ANDA Taro Pharmaceuticals U.S.A., inc. 51672-1386 N 51672-1386-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jun 10, 1987TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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US Department of Justice
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