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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075043

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NDA 075043 describes HYDROCORTISONE VALERATE, which is a drug marketed by G And W Labs Inc, Perrigo New York, Taro, and Fougera Pharms, and is included in five NDAs. It is available from three suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.

The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There are sixty-four drug master file entries for this compound. Three 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
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 G&W Laboratories, Inc. 0713-0669 N 0713-0669-60
HYDROCORTISONE VALERATE hydrocortisone valerate OINTMENT;TOPICAL 075043 ANDA G&W Laboratories, Inc. 0713-0669 N 0713-0669-37

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Julphar
Johnson and Johnson
Chinese Patent Office
Merck
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