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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075671

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NDA 075671 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 075671

Tradename:	MEGESTROL ACETATE
Applicant:	Strides Pharma Intl
Ingredient:	megestrol acetate
Patents:	0

Pharmacology for NDA: 075671

Medical Subject Heading (MeSH) Categories for 075671

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 075671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075671	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0945	0121-0945-00	10 TRAY in 1 CASE (0121-0945-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	075671	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0945	0121-0945-40	4 TRAY in 1 CASE (0121-0945-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Jul 25, 2001	TE:	AB	RLD:	No

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