Details for New Drug Application (NDA): 078921

NDA 078921 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, Norvium Bioscience, 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 078921

Tradename:	ANASTROZOLE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	anastrozole
Patents:	0

Pharmacology for NDA: 078921

Mechanism of Action

Aromatase Inhibitors

Suppliers and Packaging for NDA: 078921

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANASTROZOLE	anastrozole	TABLET;ORAL	078921	ANDA	American Health Packaging	60687-112	60687-112-21	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-112-21) / 1 TABLET, COATED in 1 BLISTER PACK (60687-112-11)
ANASTROZOLE	anastrozole	TABLET;ORAL	078921	ANDA	Zydus Lifesciences Limited	65841-743	65841-743-06	30 TABLET, COATED in 1 BOTTLE (65841-743-06)

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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