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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079110

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NDA 079110 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Fresenius Kabi Usa, Kenton, Kudco Ireland, Mylan, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.
Summary for 079110
Tradename:BICALUTAMIDE
Applicant:Sun Pharm
Ingredient:bicalutamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079110
Mechanism of ActionAndrogen Receptor Antagonists
Suppliers and Packaging for NDA: 079110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICALUTAMIDE bicalutamide TABLET;ORAL 079110 ANDA Sun Pharmaceutical Industries, Inc. 47335-485 47335-485-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-485-08)
BICALUTAMIDE bicalutamide TABLET;ORAL 079110 ANDA Sun Pharmaceutical Industries, Inc. 47335-485 47335-485-18 1000 TABLET, FILM COATED in 1 BOTTLE (47335-485-18)

Profile for product number 001

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

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