Last Updated: November 10, 2026

Details for New Drug Application (NDA): 211390

NDA 211390 describes ZILEUTON, which is a drug marketed by Aizant, Annora Pharma, Lupin, Rising, Strides Pharma Intl, 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the zileuton profile page.

Summary for 211390

Tradename:	ZILEUTON
Applicant:	Aizant
Ingredient:	zileuton
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Oct 23, 2020	TE:	AB	RLD:	No

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