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Serving leading biopharmaceutical companies globally:

Chubb
Federal Trade Commission
Farmers Insurance
McKinsey
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McKesson
Argus Health
Fuji
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Generated: December 11, 2017

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 twenty 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-one suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for 079089

Tradename:1
Applicant:1
Ingredient:1
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 65841-613-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-613-01)
BICALUTAMIDE bicalutamide TABLET;ORAL 079089 ANDA Cadila Healthcare Limited 65841-613 65841-613-06 30 TABLET, FILM COATED in 1 BOTTLE (65841-613-06)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Deloitte
Queensland Health
Express Scripts
US Army
Merck
Federal Trade Commission
Moodys
Fish and Richardson
Novartis
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