Last Updated: September 25, 2026

Details for New Drug Application (NDA): 210323

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NDA 210323 describes EXEMESTANE, which is a drug marketed by Amneal Pharms, Breckenridge, Cipla, Dr Reddys Labs Sa, Eirgen, Eugia Pharma, Hikma, Qilu, Rising, Upsher Smith Labs, and Zydus Pharms, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the EXEMESTANE profile page.

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

Summary for 210323

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

Pharmacology for NDA: 210323

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 210323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXEMESTANE	exemestane	TABLET;ORAL	210323	ANDA	Cipla USA Inc.	69097-316	69097-316-02	30 TABLET in 1 BOTTLE (69097-316-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 27, 2018	TE:	AB	RLD:	No

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