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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Express Scripts
Farmers Insurance
US Department of Justice
Healthtrust
Citi
Medtronic
Deloitte

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075325

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NDA 075325 describes EMBELINE E, which is a drug marketed by Hi Tech Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the EMBELINE E profile page.

The generic ingredient in EMBELINE E is clobetasol propionate. There are thirteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075325
Tradename:EMBELINE E
Applicant:Hi Tech Pharma
Ingredient:clobetasol propionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075325
Medical Subject Heading (MeSH) Categories for 075325
Suppliers and Packaging for NDA: 075325
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBELINE E clobetasol propionate CREAM;TOPICAL 075325 ANDA Hi-Tech Pharmacal Co., Inc. 50383-270 N 50383-270-15
EMBELINE E clobetasol propionate CREAM;TOPICAL 075325 ANDA Hi-Tech Pharmacal Co., Inc. 50383-270 N 50383-270-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.05%
Approval Date:Dec 24, 1998TE:AB2RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Baxter
Mallinckrodt
Accenture
Citi
Dow
Boehringer Ingelheim
Julphar
Fuji

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