APPLICATION
ANDA090801
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-12
LATEST ACTION
2023-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
URSODIOLPrescription
URSODIOL 500MG · TABLET · ORAL
URSODIOLPrescription
URSODIOL 250MG · TABLET · ORAL
Approval history
2023-04-25Labeling · Supplement 8 · standardAP
2021-11-29Labeling · Supplement 5 · standardAP
2015-10-26Labeling · Supplement 1 · standardAP
2011-07-12OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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