Application Nr Approved Date Route Status External Links
ANDA213069 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Febuxostat Tablet Is A Xanthine Oxidase (Xo) Inhibitor Indicated For The Chronic Management Of Hyperuricemia In Adult Patients With Gout Who Have An Inadequate Response To A Maximally Titrated Dose Of Allopurinol, Who Are Intolerant To Allopurinol, Or For Whom Treatment With Allopurinol Is Not Advisable. For The Safe And Effective Use Of Allopurinol, See Allopurinol Prescribing Information. Febuxostat Tablet Is A Xanthine Oxidase (Xo) Inhibitor Indicated For The Chronic Management Of Hyperuricemia In Adult Patients With Gout Who Have An Inadequate Response To A Maximally Titrated Dose Of Allopurinol, Who Are Intolerant To Allopurinol, Or For Whom Treatment With Allopurinol Is Not Advisable. ( 1 ) For The Safe And Effective Use Of Allopurinol, See Allopurinol Prescribing Information. Limitations Of Use : Febuxostat Tablets Are Not Recommended For The Treatment Of Asymptomatic Hyperuricemia. ( 1 ) Limitations Of Use : Febuxostat Tablets Are Not Recommended For The Treatment Of Asymptomatic Hyperuricemia.febuxostat Tablets Are Not Recommended For The Treatment Of Asymptomatic Hyperuricemia.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Febuxostat FEBUXOSTAT ZINC5423

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