Last Updated: May 11, 2026

Details for New Drug Application (NDA): 209614

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NDA 209614 describes ENZALUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, and Zydus Pharms, and is included in three NDAs. Additional details are available on the ENZALUTAMIDE profile page.

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

Summary for 209614

Tradename:	ENZALUTAMIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	enzalutamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	May 14, 2021	TE:		RLD:	No

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