Last Updated: September 24, 2026

Details for New Drug Application (NDA): 213724

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NDA 213724 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 213724

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

Pharmacology for NDA: 213724

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 213724

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724	ANDA	Cosette Pharmaceuticals, Inc.	0713-0720	0713-0720-15	1 TUBE in 1 CARTON (0713-0720-15) / 15 g in 1 TUBE
HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724	ANDA	Cosette Pharmaceuticals, Inc.	0713-0720	0713-0720-37	1 TUBE in 1 CARTON (0713-0720-37) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.2%
Approval Date:	Feb 11, 2021	TE:	AB	RLD:	No

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