Last Updated: November 10, 2026

Details for New Drug Application (NDA): 217113

NDA 217113 describes APALUTAMIDE, which is a drug marketed by Zydus Lifesciences and is included in one NDA. Additional details are available on the APALUTAMIDE profile page.

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

Summary for 217113

Tradename:	APALUTAMIDE
Applicant:	Zydus Lifesciences
Ingredient:	apalutamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Mar 17, 2025	TE:	AB	RLD:	No

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