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FDA NDA · NDA020675

URSO 250

ursodiol

Sponsor: ABBVIE

APPLICATION
NDA020675
TYPE
NDA
ORIGINAL APPROVAL
1997-12-10
LATEST ACTION
2023-01-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

URSO 250 · ReferenceDiscontinued
URSODIOL 250MG · TABLET · ORAL
URSO FORTE · ReferenceDiscontinued
URSODIOL 500MG · TABLET · ORAL

Approval history

2023-01-12Labeling · Supplement 28 · standard — Letter ↗AP
2021-05-07Labeling · Supplement 27 · standard — Letter ↗AP
2013-09-11Manufacturing (CMC) · Supplement 25 · standardAP
2013-08-21Manufacturing (CMC) · Supplement 24 · standardAP
2013-08-19Manufacturing (CMC) · Supplement 23 · standardAP
2013-06-14Labeling · Supplement 22 · standard — Letter ↗AP
2013-02-27Manufacturing (CMC) · Supplement 21 · standardAP
2009-11-25Labeling · Supplement 17 · standard — Label ↗AP
2008-03-10Manufacturing (CMC) · Supplement 13 — Label ↗AP
2004-09-24Labeling · Supplement 11 · standard — Letter ↗AP
2004-07-21Efficacy · Supplement 9 · standard — Letter ↗AP
2001-03-08Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2001-03-08Labeling · Supplement 7 · standard — Letter ↗AP
2001-02-02Manufacturing (CMC) · Supplement 2 · standardAP
2001-01-30Manufacturing (CMC) · Supplement 5 · standardAP
2000-02-08Manufacturing (CMC) · Supplement 4 · standardAP
1998-04-17Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-10Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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