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Generated: August 25, 2019

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Details for New Drug Application (NDA): 204929

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NDA 204929 describes ZILEUTON, which is a drug marketed by Rising and is included in one NDA. It is available from one supplier. 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. Three suppliers are listed for this compound. Additional details are available on the zileuton profile page.
Summary for 204929
Formulation / Manufacturing:see details
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 Pharmaceuticals, 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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