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Generated: November 18, 2018

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Details for New Drug Application (NDA): 074221

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NDA 074221 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 fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 074221
Tradename:EMBELINE
Applicant:Hi Tech Pharma
Ingredient:clobetasol propionate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074221
Medical Subject Heading (MeSH) Categories for 074221
Suppliers and Packaging for NDA: 074221
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBELINE clobetasol propionate OINTMENT;TOPICAL 074221 ANDA Rebel Distributors Corp 42254-174 42254-174-45 1 TUBE in 1 CARTON (42254-174-45) > 45 g in 1 TUBE
EMBELINE clobetasol propionate OINTMENT;TOPICAL 074221 ANDA Hi-Tech Pharmacal Co., Inc. 50383-268 50383-268-15 1 TUBE in 1 CARTON (50383-268-15) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.05%
Approval Date:Mar 31, 1995TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Dow

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