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Deloitte
Cantor Fitzgerald
Farmers Insurance
Healthtrust
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Dow
Cerilliant
Colorcon
Novartis

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079089

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NDA 079089 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 079089
Tradename:BICALUTAMIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:bicalutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 079089
Mechanism of ActionAndrogen Receptor Antagonists
Suppliers and Packaging for NDA: 079089
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 079089 ANDA Cadila Healthcare Limited 65841-613 N 65841-613-01
BICALUTAMIDE bicalutamide TABLET;ORAL 079089 ANDA Cadila Healthcare Limited 65841-613 N 65841-613-06

Profile for product number 001

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

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