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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 200898

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NDA 200898 describes EXEMESTANE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the EXEMESTANE profile page.

The generic ingredient in EXEMESTANE is exemestane. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the exemestane profile page.

Summary for 200898

Tradename:	EXEMESTANE
Applicant:	Alvogen
Ingredient:	exemestane
Patents:	0

Pharmacology for NDA: 200898

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 200898

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXEMESTANE	exemestane	TABLET;ORAL	200898	ANDA	Eirgen Pharma Ltd	44278-025	44278-025-30	30 TABLET in 1 BOTTLE (44278-025-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Jul 28, 2014	TE:		RLD:	No

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