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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078944

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NDA 078944 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 078944

Tradename:	ANASTROZOLE
Applicant:	Kenton
Ingredient:	anastrozole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jun 28, 2010	TE:	AB	RLD:	No

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