Last Updated: May 11, 2026

Details for New Drug Application (NDA): 020169

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NDA 020169 describes NILANDRON, which is a drug marketed by Advanz Pharma and is included in one NDA. Additional details are available on the NILANDRON profile page.

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

Summary for 020169

Tradename:	NILANDRON
Applicant:	Advanz Pharma
Ingredient:	nilutamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 19, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Apr 30, 1999	TE:	AB	RLD:	Yes

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