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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Merck
Cipla
US Department of Justice
Julphar
US Army
Chinese Patent Office
Johnson and Johnson
Cerilliant
Teva

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078634

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NDA 078634 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 078634
Tradename:BICALUTAMIDE
Applicant:Watson Labs Teva
Ingredient:bicalutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 078634
Mechanism of ActionAndrogen Receptor Antagonists
Suppliers and Packaging for NDA: 078634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 078634 ANDA Northstar RxLLC 16714-571 N 16714-571-01
BICALUTAMIDE bicalutamide TABLET;ORAL 078634 ANDA Northstar RxLLC 16714-571 N 16714-571-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 28, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Army
Deloitte
Merck
Harvard Business School
Cantor Fitzgerald
UBS
Chinese Patent Office
Boehringer Ingelheim

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