APPLICATION
ANDA210344
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-22
LATEST ACTION
2025-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
URSODIOLPrescription
URSODIOL 300MG · CAPSULE · ORAL
URSODIOLPrescription
URSODIOL 150MG · CAPSULE · ORAL
Approval history
2025-11-21Labeling · Supplement 6 · standardAP
2023-10-25Labeling · Supplement 3 · standardAP
2021-01-22UNKNOWN · Original · standardAP
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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