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Generated: November 17, 2018

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Details for New Drug Application (NDA): 075430

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NDA 075430 describes CLOBETASOL PROPIONATE (EMOLLIENT), which is a drug marketed by Fougera Pharms, Novast Labs, Taro, and Teligent Pharma Inc, and is included in four NDAs. It is available from five suppliers. Additional details are available on the CLOBETASOL PROPIONATE (EMOLLIENT) profile page.

The generic ingredient in CLOBETASOL PROPIONATE (EMOLLIENT) is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075430
Tradename:CLOBETASOL PROPIONATE (EMOLLIENT)
Applicant:Fougera Pharms
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075430
Medical Subject Heading (MeSH) Categories for 075430
Suppliers and Packaging for NDA: 075430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075430 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0301 0168-0301-15 1 TUBE in 1 CARTON (0168-0301-15) > 15 g in 1 TUBE
CLOBETASOL PROPIONATE (EMOLLIENT) clobetasol propionate CREAM;TOPICAL 075430 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0301 0168-0301-30 1 TUBE in 1 CARTON (0168-0301-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:May 26, 1999TE:AB2RLD:No

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