Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078917

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NDA 078917 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 078917

Tradename:	BICALUTAMIDE
Applicant:	Accord Hlthcare
Ingredient:	bicalutamide
Patents:	0

Pharmacology for NDA: 078917

Mechanism of Action	Androgen Receptor Antagonists

Suppliers and Packaging for NDA: 078917

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Accord Healthcare Inc.	16729-023	16729-023-01	100 TABLET in 1 BOTTLE (16729-023-01)
BICALUTAMIDE	bicalutamide	TABLET;ORAL	078917	ANDA	Accord Healthcare Inc.	16729-023	16729-023-10	30 TABLET in 1 BOTTLE (16729-023-10)

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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