Last Updated: June 17, 2026

Details for New Drug Application (NDA): 076721

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NDA 076721 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 sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the megestrol acetate profile page.

Summary for 076721

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

Pharmacology for NDA: 076721

Medical Subject Heading (MeSH) Categories for 076721

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 076721

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721	ANDA	Xttrium Laboratories, Inc.	0116-4011	0116-4011-08	237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	076721	ANDA	Xttrium Laboratories, Inc.	0116-4011	0116-4011-11	10 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Nov 1, 2004	TE:	AB	RLD:	No

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