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Generated: May 29, 2017

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Details for New Drug Application (NDA): 076364

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NDA 076364 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Taro, Glenmark Generics, and Taro Pharm Inds, 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. Nine suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

Summary for NDA: 076364

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076364

Suppliers and Packaging for NDA: 076364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone butyrate
SOLUTION;TOPICAL 076364 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4061 51672-4061-2 1 BOTTLE in 1 CARTON (51672-4061-2) > 20 mL in 1 BOTTLE
hydrocortisone butyrate
SOLUTION;TOPICAL 076364 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4061 51672-4061-4 1 BOTTLE in 1 CARTON (51672-4061-4) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.1%
Approval Date:Jan 14, 2004TE:ATRLD:No

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