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Last Updated: November 2, 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 Action5-Lipoxygenase Inhibitors
Physiological EffectDecreased 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Mar 17, 2017TE:ABRLD:No

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