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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019966

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NDA 019966 describes TEMOVATE, which is a drug marketed by Fougera Pharms and is included in five NDAs. It is available from one supplier. Additional details are available on the TEMOVATE profile page.

The generic ingredient in TEMOVATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 019966
Applicant:Fougera Pharms
Ingredient:clobetasol propionate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019966
Medical Subject Heading (MeSH) Categories for 019966
Suppliers and Packaging for NDA: 019966
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOVATE clobetasol propionate SOLUTION;TOPICAL 019966 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 0462-0269 0462-0269-50 50 mL in 1 BOTTLE, PLASTIC (0462-0269-50)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 22, 1990TE:RLD:Yes

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