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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
US Department of Justice
Chinese Patent Office

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076654

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NDA 076654 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Glenmark Generics, Taro Pharm Inds, and Taro, and is included in four NDAs. It is available from two suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 076654
Applicant:Taro Pharm Inds
Ingredient:hydrocortisone butyrate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076654
Suppliers and Packaging for NDA: 076654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4074 51672-4074-1 1 TUBE in 1 CARTON (51672-4074-1) > 15 g in 1 TUBE
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4074 51672-4074-6 1 TUBE in 1 CARTON (51672-4074-6) > 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Aug 3, 2005TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts

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