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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077973

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NDA 077973 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 077973

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

Pharmacology for NDA: 077973

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 077973

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 077973 ANDA Synthon Pharmaceuticals, Inc. 63672-0005 63672-0005-0 50000 TABLET, FILM COATED in 1 DRUM (63672-0005-0)
BICALUTAMIDE bicalutamide TABLET;ORAL 077973 ANDA Dava Pharmaceuticals, Inc. 67253-191 67253-191-03 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67253-191-03)

Summary for product number 001

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


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Healthtrust
Argus Health
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