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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 080828

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NDA 080828 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 080828

Tradename:	HYDROCORTISONE ACETATE
Applicant:	Fera Pharms
Ingredient:	hydrocortisone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	0.5%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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