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Generated: April 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020337

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NDA 020337 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-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for NDA: 020337

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020337

Suppliers and Packaging for NDA: 020337

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOVATE
clobetasol propionate
GEL;TOPICAL 020337 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 0462-0293 0462-0293-60 1 TUBE in 1 CARTON (0462-0293-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 29, 1994TE:RLD:Yes


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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.

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