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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 040259

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NDA 040259 describes HYDROCORTISONE ACETATE, which is a drug marketed by Cenci, Imperium, Parke Davis, Purepac Pharm, Bel Mar, Epic Pharma Llc, Watson Labs, Fera Pharms, X Gen Pharms, and Genus, and is included in thirteen NDAs. Additional details are available on the HYDROCORTISONE ACETATE profile page.

The generic ingredient in HYDROCORTISONE ACETATE is hydrocortisone acetate; pramoxine hydrochloride. 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 acetate; pramoxine hydrochloride profile page.

Summary for 040259

Tradename:	HYDROCORTISONE ACETATE
Applicant:	Imperium
Ingredient:	hydrocortisone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	2.5%
Approval Date:	Jul 29, 1999	TE:		RLD:	No

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