Application Nr Approved Date Route Status External Links
NDA204820 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Mitigare ® (Colchicine) Capsules Are Indicated For Prophylaxis Of Gout Flares In Adults. Limitations Of Use: The Safety And Effectiveness Of Mitigare ® For Acute Treatment Of Gout Flares During Prophylaxis Has Not Been Studied. Mitigare ® Is Not An Analgesic Medication And Should Not Be Used To Treat Pain From Other Causes. Mitigare ® Is Indicated For Prophylaxis Of Gout Flares In Adults ( 1 ). Limitations Of Use: The Safety And Effectiveness Of Mitigare ® For Acute Treatment Of Gout Flares During Prophylaxis Has Not Been Studied. Mitigare ® Is Not An Analgesic Medication And Should Not Be Used To Treat Pain From Other Causes.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Colchicine COLCHICINE ZINC621853

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