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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212434

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NDA 212434 describes ANASTROZOLE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Beijing Yiling, Chartwell Molecular, Chartwell Rx, Cipla, Eugia Pharma, Fresenius Kabi Usa, Hikma, Impax Labs Inc, Kenton, Natco Pharma Ltd, Pharmobedient, Sandoz, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from twenty-four suppliers. Additional details are available on the ANASTROZOLE profile page.

The generic ingredient in ANASTROZOLE is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

Summary for 212434

Tradename:	ANASTROZOLE
Applicant:	Eugia Pharma
Ingredient:	anastrozole
Patents:	0

Pharmacology for NDA: 212434

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 212434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANASTROZOLE	anastrozole	TABLET;ORAL	212434	ANDA	Aurobindo Pharma Limited	59651-236	59651-236-30	30 TABLET, FILM COATED in 1 BOTTLE (59651-236-30)
ANASTROZOLE	anastrozole	TABLET;ORAL	212434	ANDA	Aurobindo Pharma Limited	59651-236	59651-236-90	90 TABLET, FILM COATED in 1 BOTTLE (59651-236-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 24, 2020	TE:	AB	RLD:	No

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