APPLICATION
ANDA075517
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-14
LATEST ACTION
2024-04-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
URSODIOLPrescription
URSODIOL 300MG · CAPSULE · ORAL
Approval history
2024-04-30Labeling · Supplement 18 · standardAP
2015-04-06Labeling · Supplement 11AP
2007-08-30Labeling · Supplement 6AP
2005-04-11Labeling · Supplement 4AP
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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