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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Dow
Fuji
Daiichi Sankyo
Mallinckrodt
Cipla
Express Scripts
Fish and Richardson
US Department of Justice

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079185

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NDA 079185 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 079185
Tradename:BICALUTAMIDE
Applicant:Mylan
Ingredient:bicalutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

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:

Accenture
US Army
Argus Health
Julphar
Queensland Health
Chinese Patent Office
Farmers Insurance
Express Scripts
Johnson and Johnson

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