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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 211047

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NDA 211047 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 211047

Tradename:	HYDROCORTISONE VALERATE
Applicant:	Encube Ethicals
Ingredient:	hydrocortisone valerate
Patents:	0

Pharmacology for NDA: 211047

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 211047

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Encube Ethicals, Inc.	21922-007	21922-007-04	1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE
HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	211047	ANDA	Encube Ethicals, Inc.	21922-007	21922-007-06	1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.2%
Approval Date:	Nov 4, 2021	TE:	AB	RLD:	No

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