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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 079110

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NDA 079110 describes BICALUTAMIDE, which is a drug marketed by Accord Hlthcare, Adaptis, Apotex, Chartwell Rx, Fresenius Kabi Usa, Kudco Ireland, Rising, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, and Watson Labs Teva, 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

Pharmacology for NDA: 079110

Mechanism of Action	Androgen 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:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jul 6, 2009	TE:	AB	RLD:	No

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