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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203315

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NDA 203315 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 ten 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. Twelve suppliers are listed for this compound. Additional details are available on the exemestane profile page.

Summary for 203315

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 10, 2017	TE:	AB	RLD:	No

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