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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078921

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NDA 078921 describes ANASTROZOLE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Cipla Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Impax Labs Inc, Lannett Co Inc, Mylan, Natco Pharma Ltd, Sandoz, Santos Biotech, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Watson Labs Teva, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from twenty-eight 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-nine 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
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078921
Mechanism of ActionAromatase 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 N 60687-112-21
ANASTROZOLE anastrozole TABLET;ORAL 078921 ANDA Cadila Healthcare Limited 65841-743 N 65841-743-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 28, 2010TE:ABRLD:No

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