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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213547

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NDA 213547 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 213547

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

Pharmacology for NDA: 213547

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 213547

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXEMESTANE	exemestane	TABLET;ORAL	213547	ANDA	Florida Pharmaceutical Products, LLC	71921-190	71921-190-33	30 TABLET, FILM COATED in 1 BOTTLE (71921-190-33)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Apr 13, 2020	TE:	AB	RLD:	No

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