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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075666

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NDA 075666 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 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 075666
Applicant:Perrigo New York
Ingredient:hydrocortisone valerate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075666
Suppliers and Packaging for NDA: 075666
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 075666 ANDA Perrigo New York Inc 45802-455 45802-455-42 1 TUBE in 1 CARTON (45802-455-42) > 45 g in 1 TUBE
HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 075666 ANDA Perrigo New York Inc 45802-455 45802-455-37 1 TUBE in 1 CARTON (45802-455-37) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.2%
Approval Date:May 24, 2000TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Boehringer Ingelheim
Harvard Business School

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