Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075085

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NDA 075085 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette Pharms Nc, Encube Ethicals, Glenmark Pharms Ltd, Lupin, Padagis Israel, Sun Pharma Canada, and Fougera Pharms, and is included in eleven 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.

Summary for 075085

Tradename:	HYDROCORTISONE VALERATE
Applicant:	Fougera Pharms
Ingredient:	hydrocortisone valerate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.2%
Approval Date:	Jul 31, 2001	TE:		RLD:	No

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