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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 072422

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NDA 072422 describes MEGESTROL ACETATE, which is a drug marketed by Chartwell, Hikma, Novitium Pharma, Strides Pharma, Teva Pharms, Twi Pharms, Xttrium Labs Inc, 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 072422

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

Pharmacology for NDA: 072422

Medical Subject Heading (MeSH) Categories for 072422

Antineoplastic Agents, Hormonal
Appetite Stimulants
Contraceptives, Oral, Synthetic

Suppliers and Packaging for NDA: 072422

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEGESTROL ACETATE	megestrol acetate	TABLET;ORAL	072422	ANDA	Strides Pharma Science Limited	64380-158	64380-158-01	100 TABLET in 1 BOTTLE (64380-158-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 8, 1988	TE:	AB	RLD:	No

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