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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202145

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NDA 202145 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 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 202145
Applicant:Glenmark Generics
Ingredient:hydrocortisone butyrate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 202145
Suppliers and Packaging for NDA: 202145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145 ANDA Glenmark Pharmaceuticals Inc., USA 68462-464 68462-464-17 15 g in 1 CARTON (68462-464-17)
HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM;TOPICAL 202145 ANDA Glenmark Pharmaceuticals Inc., USA 68462-464 68462-464-65 60 g in 1 CARTON (68462-464-65)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Sep 27, 2013TE:AB2RLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Express Scripts

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