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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075043


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NDA 075043 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette, Encube Ethicals, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Taro, and Fougera Pharms, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.

The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There are sixty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.
Summary for 075043
Tradename:HYDROCORTISONE VALERATE
Applicant:Taro
Ingredient:hydrocortisone valerate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075043
Suppliers and Packaging for NDA: 075043
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE VALERATE hydrocortisone valerate OINTMENT;TOPICAL 075043 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1292 51672-1292-1 1 TUBE in 1 CARTON (51672-1292-1) / 15 g in 1 TUBE
HYDROCORTISONE VALERATE hydrocortisone valerate OINTMENT;TOPICAL 075043 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1292 51672-1292-3 1 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength0.2%
Approval Date:Aug 25, 1998TE:ABRLD:No

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