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Last Updated: December 24, 2024

Details for New Drug Application (NDA): 211972

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NDA 211972 describes ZILEUTON, which is a drug marketed by Aizant, Annora Pharma, Lupin Ltd, Rising, Strides Pharma, and Teva Pharms Usa, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ZILEUTON profile page.

The generic ingredient in ZILEUTON is zileuton. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.

Summary for 211972

Tradename:	ZILEUTON
Applicant:	Lupin Ltd
Ingredient:	zileuton
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Nov 5, 2019	TE:		RLD:	No

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