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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 211750

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NDA 211750 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 211750

Tradename:	HYDROCORTISONE VALERATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	hydrocortisone valerate
Patents:	0

Pharmacology for NDA: 211750

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 211750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	211750	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-836	68462-836-17	1 TUBE in 1 CARTON (68462-836-17) / 15 g in 1 TUBE
HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	211750	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-836	68462-836-47	1 TUBE in 1 CARTON (68462-836-47) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.2%
Approval Date:	Dec 14, 2018	TE:		RLD:	No

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