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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 078058

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NDA 078058 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-three 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-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

Summary for 078058

Tradename:	ANASTROZOLE
Applicant:	Teva Pharms
Ingredient:	anastrozole
Patents:	0

Pharmacology for NDA: 078058

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 078058

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANASTROZOLE	anastrozole	TABLET;ORAL	078058	ANDA	Teva Pharmaceuticals USA, Inc.	0093-7536	0093-7536-56	30 TABLET, FILM COATED in 1 BOTTLE (0093-7536-56)
ANASTROZOLE	anastrozole	TABLET;ORAL	078058	ANDA	AvKARE	42291-085	42291-085-30	30 TABLET, FILM COATED in 1 BOTTLE (42291-085-30)

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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