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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

Summary for 074221

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Boehringer Ingelheim
Farmers Insurance
Express Scripts
Fish and Richardson

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