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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 075997

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NDA 075997 describes MEGESTROL ACETATE, which is a drug marketed by Chartwell, Hikma, Novitium Pharma, Pharmobedient, Strides Pharma Intl, Teva Pharms, Twi Pharms, Barr, Teva, and Usl Pharma, and is included in fifteen NDAs. It is available from fifteen suppliers. Additional details are available on the MEGESTROL ACETATE profile page.

The generic ingredient in MEGESTROL ACETATE is megestrol acetate. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for 075997

Tradename:	MEGESTROL ACETATE
Applicant:	Hikma
Ingredient:	megestrol acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075997

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Feb 15, 2002	TE:		RLD:	No

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