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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202145

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NDA 202145 describes HYDROCORTISONE BUTYRATE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Lupin Ltd, The J Molner, and Taro, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

Summary for 202145

Tradename:	HYDROCORTISONE BUTYRATE
Applicant:	Glenmark Pharms Ltd
Ingredient:	hydrocortisone butyrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Sep 27, 2013	TE:		RLD:	No

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