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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078285

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NDA 078285 describes BICALUTAMIDE, which is a drug marketed by Sun Pharma Global, Santos Biotech, Accord Hlthcare, Teva, Watson Labs Teva, Fresenius Kabi Oncol, Synthon Pharms, Apotex Inc, Sandoz, Mylan, Roxane, Zydus Pharms Usa Inc, and Kudco Ireland, and is included in thirteen NDAs. It is available from twenty-one 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. Twenty-two suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for NDA: 078285

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Mar 24, 2011TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Accenture
Cerilliant
Argus Health
Julphar
Express Scripts
Daiichi Sankyo
AstraZeneca
Fuji

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