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Generated: November 15, 2018

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Details for New Drug Application (NDA): 074204

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NDA 074204 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 074204
Tradename:FLUOCINONIDE EMULSIFIED BASE
Applicant:G And W Labs Inc
Ingredient:fluocinonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074204
Medical Subject Heading (MeSH) Categories for 074204
Suppliers and Packaging for NDA: 074204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 074204 ANDA Impax Generics 0115-1705 0115-1705-52 1 TUBE in 1 CARTON (0115-1705-52) > 15 g in 1 TUBE
FLUOCINONIDE EMULSIFIED BASE fluocinonide CREAM;TOPICAL 074204 ANDA Impax Generics 0115-1706 0115-1706-45 1 TUBE in 1 CARTON (0115-1706-45) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Jun 13, 1995TE:AB2RLD:No

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