Ursodiol

Product manufactured by Kvk-Tech, Inc.

Application Nr Approved Date Route Status External Links
ANDA210707 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ursodiol Capsules Are Indicated For Patients With Radiolucent, Noncalcified Gallbladder Stones < 20 Mm In Greatest Diameter In Whom Elective Cholecystectomy Would Be Undertaken Except For The Presence Of Increased Surgical Risk Due To Systemic Disease, Advanced Age, Idiosyncratic Reaction To General Anesthesia, Or For Those Patients Who Refuse Surgery. Safety Of Use Of Ursodiol Capsules Beyond 24 Months Is Not Established. Ursodiol Capsules Are Indicated For The Prevention Of Gallstone Formation In Obese Patients Experiencing Rapid Weight Loss.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ursadiol

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