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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
McKesson
US Department of Justice
Argus Health
Citi
Accenture
Merck
Dow
UBS

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076141

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NDA 076141 describes EMBELINE, which is a drug marketed by Hi Tech Pharma and is included in four NDAs. It is available from six suppliers. Additional details are available on the EMBELINE profile page.

The generic ingredient in EMBELINE 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: 076141

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

Pharmacology for NDA: 076141

Suppliers and Packaging for NDA: 076141

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBELINE
clobetasol propionate
GEL;TOPICAL 076141 ANDA Hi-Tech Pharmacal Co., Inc. 50383-269 50383-269-15 1 TUBE in 1 CARTON (50383-269-15) > 15 g in 1 TUBE
EMBELINE
clobetasol propionate
GEL;TOPICAL 076141 ANDA Hi-Tech Pharmacal Co., Inc. 50383-269 50383-269-30 1 TUBE in 1 CARTON (50383-269-30) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.05%
Approval Date:Apr 12, 2002TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Moodys
Colorcon
QuintilesIMS
Chubb
Citi
Harvard Business School
Daiichi Sankyo
Fuji
Covington
McKesson

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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