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

Tradename:	TEMOVATE
Applicant:	Fougera Pharms
Ingredient:	clobetasol propionate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019966

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 019966

Anti-Inflammatory Agents
Glucocorticoids

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:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Feb 22, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019966

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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