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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205134

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NDA 205134 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 four 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. Six suppliers are listed for this compound. Additional details are available on the hydrocortisone butyrate profile page.

Summary for 205134

Tradename:	HYDROCORTISONE BUTYRATE
Applicant:	Actavis Mid Atlantic
Ingredient:	hydrocortisone butyrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Dec 8, 2017	TE:	AB2	RLD:	No

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