Last Updated: November 8, 2026

Details for New Drug Application (NDA): 079045

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NDA 079045 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 six suppliers. Additional details are available on the BICALUTAMIDE profile page.

The generic ingredient in BICALUTAMIDE is bicalutamide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

Summary for 079045

Tradename:	BICALUTAMIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	bicalutamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 13, 2010	TE:		RLD:	No

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