Last Updated: September 24, 2026

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, The J Molner, and Taro, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the HYDROCORTISONE BUTYRATE profile page.

The generic ingredient in HYDROCORTISONE BUTYRATE is hydrocortisone butyrate. There is one drug master file entry for this compound. Six 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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