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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Chubb
Chinese Patent Office
Cerilliant
QuintilesIMS
Covington
Fuji
Accenture
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078322

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NDA 078322 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-one 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-two suppliers are listed for this compound. Additional details are available on the anastrozole profile page.
Summary for 078322
Tradename:ANASTROZOLE
Applicant:Synthon Pharms
Ingredient:anastrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078322
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 078322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANASTROZOLE anastrozole TABLET;ORAL 078322 ANDA Synthon Pharmaceuticals, Inc. 63672-0015 63672-0015-0 50000 TABLET, FILM COATED in 1 DRUM (63672-0015-0)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Healthtrust
Baxter
Argus Health
McKinsey
Medtronic
Johnson and Johnson
Fish and Richardson
US Army
Federal Trade Commission

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