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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Federal Trade Commission
Queensland Health
Fish and Richardson
Harvard Business School

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075042

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NDA 075042 describes HYDROCORTISONE VALERATE, which is a drug marketed by Taro, Perrigo New York, Fougera Pharms, and G And W Labs Inc, and is included in five NDAs. It is available from six suppliers. Additional details are available on the HYDROCORTISONE VALERATE profile page.

The generic ingredient in HYDROCORTISONE VALERATE is hydrocortisone valerate. There are sixty drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.

Summary for NDA: 075042

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

Pharmacology for NDA: 075042

Suppliers and Packaging for NDA: 075042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
hydrocortisone valerate
CREAM;TOPICAL 075042 ANDA G&W Laboratories, Inc. 0713-0668 0713-0668-15 1 TUBE in 1 CARTON (0713-0668-15) > 15 g in 1 TUBE
hydrocortisone valerate
CREAM;TOPICAL 075042 ANDA G&W Laboratories, Inc. 0713-0668 0713-0668-37 1 TUBE in 1 CARTON (0713-0668-37) > 45 g in 1 TUBE

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
US Army
Queensland Health
Farmers Insurance
Fish and Richardson

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