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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 203139

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NDA 203139 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 203139

Tradename:	MEGESTROL ACETATE
Applicant:	Twi Pharms
Ingredient:	megestrol acetate
Patents:	0

Pharmacology for NDA: 203139

Medical Subject Heading (MeSH) Categories for 203139

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 203139

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203139	ANDA	Upsher-Smith Laboratories, LLC	24979-041	24979-041-13	150 mL in 1 BOTTLE (24979-041-13)
MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	203139	ANDA	Proficient Rx LP	71205-943	71205-943-15	150 mL in 1 BOTTLE (71205-943-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	125MG/ML
Approval Date:	Aug 27, 2014	TE:		RLD:	No

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