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Generated: November 19, 2018

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Details for New Drug Application (NDA): 072494

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NDA 072494 describes FLUOCINONIDE EMULSIFIED BASE, which is a drug marketed by Fougera Pharms, G And W Labs Inc, Taro Pharm Inds Ltd, and Teva, and is included in four NDAs. It is available from five suppliers. Additional details are available on the FLUOCINONIDE EMULSIFIED BASE profile page.

The generic ingredient in FLUOCINONIDE EMULSIFIED BASE is fluocinonide. There are nine drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.
Summary for 072494
Tradename:FLUOCINONIDE EMULSIFIED BASE
Applicant:Taro Pharm Inds Ltd
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072494
Medical Subject Heading (MeSH) Categories for 072494
Suppliers and Packaging for NDA: 072494
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 072494 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1254 51672-1254-1 1 TUBE in 1 CARTON (51672-1254-1) > 15 g in 1 TUBE
FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 072494 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1254 51672-1254-2 1 TUBE in 1 CARTON (51672-1254-2) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jan 19, 1989TE:AB2RLD:No

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