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Fuji
Cerilliant
Teva
Moodys
Merck
Mallinckrodt
QuintilesIMS
Daiichi Sankyo
Cipla

Generated: April 26, 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 Actavis Mid Atlantic, Glenmark Generics, Taro Pharm Inds, Teligent Pharma Inc, and Taro, and is included in six NDAs. It is available from four 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. Nine suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.
Summary for 076654
Tradename:HYDROCORTISONE BUTYRATE
Applicant:Taro Pharm Inds
Ingredient:hydrocortisone butyrate
Patents:0
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 N 51672-4074-1
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 076654 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4074 N 51672-4074-2

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 hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Merck
Colorcon
Harvard Business School
Fuji
Mallinckrodt
Covington
Teva

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