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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 074489

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NDA 074489 describes HYDROCORTISONE VALERATE, which is a drug marketed by Cosette, Encube Ethicals, Glenmark Pharms Ltd, Lupin Ltd, 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 are sixty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone valerate profile page.

Summary for 074489

Tradename:	HYDROCORTISONE VALERATE
Applicant:	Cosette
Ingredient:	hydrocortisone valerate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.2%
Approval Date:	Aug 12, 1998	TE:		RLD:	No

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