APPLICATION
ANDA079184
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-13
LATEST ACTION
2009-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
URSODIOLDiscontinued
URSODIOL 250MG · TABLET · ORAL
URSODIOLDiscontinued
URSODIOL 500MG · TABLET · ORAL
Approval history
2009-05-13OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.