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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Covington
Medtronic
Mallinckrodt
Chubb
Harvard Business School
McKesson
Argus Health
Chinese Patent Office

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079110

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NDA 079110 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fresenius Kabi Oncol, Kudco Ireland, Mylan, Roxane, Sandoz, Santos Biotech, Sun Pharma Global, Synthon Pharms, Teva, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from twelve suppliers. Additional details are available on the BICALUTAMIDE profile page.

The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 079110
Tradename:BICALUTAMIDE
Applicant:Sun Pharma Global
Ingredient:bicalutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 079110
Mechanism of ActionAndrogen Receptor Antagonists
Suppliers and Packaging for NDA: 079110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 079110 ANDA Sun Pharma Global FZE 47335-485 N 47335-485-08
BICALUTAMIDE bicalutamide TABLET;ORAL 079110 ANDA Sun Pharma Global FZE 47335-485 N 47335-485-88

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 6, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Fuji
Medtronic
Merck
Healthtrust
Julphar
Fish and Richardson
US Army

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