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Last Updated: December 16, 2019

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 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 079089

Tradename:	BICALUTAMIDE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	bicalutamide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 079089

Mechanism of Action	Androgen 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	65841-613-05	500 TABLET, FILM COATED in 1 BOTTLE (65841-613-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 6, 2009	TE:	AB	RLD:	No

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