Application Nr Approved Date Route Status External Links
ANDA211972 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zileuton Extended-Release Tabletis Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Children 12 Years Of Age And Older. Zileuton Extended-Release Tabletis Not Indicated For Use In The Reversal Of Bronchospasm In Acute Asthma Attacks. Therapy With Zileuton Extended-Release Tablet Can Be Continued During Acute Exacerbations Of Asthma. Zileuton Extended-Release Tablet Is A Leukotriene Synthesis Inhibitor Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Children 12 Years Of Age And Older. ( 1 ) Do Not Use Zileuton Extended-Release Tablet To Treat An Acute Asthma Attack. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Zileuton ZILEUTON ZINC896731

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