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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217113

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

The generic ingredient in APALUTAMIDE is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.

Summary for 217113

Tradename:	APALUTAMIDE
Applicant:	Zydus
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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