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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091164

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NDA 091164 describes ANASTROZOLE, which is a drug marketed by Sandoz, Natco Pharma Ltd, Zydus Pharms Usa Inc, Synthon Pharms, Kremers Urban Pharms, Dr Reddys Labs Ltd, Impax Labs Inc, Santos Biotech, Mylan, Apotex Inc, Teva Pharms, Cipla Ltd, Accord Hlthcare, Sun Pharm Inds Ltd, Watson Labs Teva, West-ward Pharms Int, and Fresenius Kabi Oncol, 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 NDA: 091164

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 091164

Mechanism of ActionAromatase Inhibitors

Suppliers and Packaging for NDA: 091164

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091164 ANDA Kadmon Pharmaceuticals, LLC 66435-415 66435-415-30 30 TABLET, FILM COATED in 1 BOTTLE (66435-415-30)

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Cantor Fitzgerald
Express Scripts

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