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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200654

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NDA 200654 describes ANASTROZOLE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Cipla Ltd, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Impax Labs Inc, Kremers Urban Pharms, 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 thirty 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. Thirty-one suppliers are listed for this compound. Additional details are available on the anastrozole profile page.
Summary for 200654
Tradename:ANASTROZOLE
Applicant:Apotex Inc
Ingredient:anastrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 200654
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 200654
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANASTROZOLE anastrozole TABLET;ORAL 200654 ANDA Golden State Medical Supply, Inc. 60429-286 60429-286-90 90 TABLET, FILM COATED in 1 BOTTLE (60429-286-90)
ANASTROZOLE anastrozole TABLET;ORAL 200654 ANDA Golden State Medical Supply, Inc. 60429-286 60429-286-30 30 TABLET, FILM COATED in 1 BOTTLE (60429-286-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:May 11, 2012TE:ABRLD:No

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