Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019966

« Back to Dashboard

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 thirteen drug master file entries for this compound. Thirty-seven 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
Therapeutic Class:	Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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	N	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DISCN	Dosage:	SOLUTION;TOPICAL			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.