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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
US Army
Boehringer Ingelheim

Generated: February 19, 2018

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 four 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-nine suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 076141
Applicant:Hi Tech Pharma
Ingredient:clobetasol propionate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076141
Medical Subject Heading (MeSH) Categories for 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 N 50383-269-30
EMBELINE clobetasol propionate GEL;TOPICAL 076141 ANDA Hi-Tech Pharmacal Co., Inc. 50383-269 N 50383-269-60

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health

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