APPLICATION
ANDA211301
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
URSODIOLDiscontinued
URSODIOL 300MG · CAPSULE · ORAL
Approval history
2024-02-16Labeling · Supplement 7 · standardAP
2018-10-16UNKNOWN · 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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