APPLICATION
ANDA214295
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-16
LATEST ACTION
2023-09-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
URSODIOLPrescription
URSODIOL 300MG · CAPSULE · ORAL
Approval history
2023-09-13Labeling · Supplement 1 · standardAP
2020-10-16UNKNOWN · 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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