Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209645

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NDA 209645 describes ENZALUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Zydus Pharms, and Sandoz, and is included in four NDAs. Additional details are available on the ENZALUTAMIDE profile page.

The generic ingredient in ENZALUTAMIDE is enzalutamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

Summary for 209645

Tradename:	ENZALUTAMIDE
Applicant:	Apotex
Ingredient:	enzalutamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Apr 22, 2022	TE:		RLD:	No

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