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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Express Scripts
Chubb
US Department of Justice
Cipla
Covington
Citi
AstraZeneca

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074222

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NDA 074222 describes EMBELINE, which is a drug marketed by Hi Tech Pharma and is included in four NDAs. It is available from five 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. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 074222
Tradename:EMBELINE
Applicant:Hi Tech Pharma
Ingredient:clobetasol propionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 074222
Medical Subject Heading (MeSH) Categories for 074222
Suppliers and Packaging for NDA: 074222
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBELINE clobetasol propionate SOLUTION;TOPICAL 074222 ANDA Hi-Tech Pharmacal Co., Inc. 50383-266 N 50383-266-25
EMBELINE clobetasol propionate SOLUTION;TOPICAL 074222 ANDA Hi-Tech Pharmacal Co., Inc. 50383-266 N 50383-266-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.05%
Approval Date:Dec 6, 1995TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
UBS
Moodys
Chubb
Federal Trade Commission
Argus Health
McKesson
Chinese Patent Office
Daiichi Sankyo

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