BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Harvard Business School
Federal Trade Commission

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200274

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NDA 200274 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 200274
Applicant:Apotex Inc
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:May 21, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Express Scripts

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