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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 204929

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NDA 204929 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 204929

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

Pharmacology for NDA: 204929

Mechanism of Action	5-Lipoxygenase Inhibitors
Physiological Effect	Decreased Leukotriene Production

Suppliers and Packaging for NDA: 204929

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZILEUTON	zileuton	TABLET, EXTENDED RELEASE;ORAL	204929	ANDA	Rising Pharma Holdings, Inc.	64980-206	64980-206-12	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-206-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	600MG
Approval Date:	Mar 17, 2017	TE:	AB	RLD:	No

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