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FDA NDA · NDA019651

ASACOL

Sponsor: APIL

APPLICATION
NDA019651
TYPE
NDA
ORIGINAL APPROVAL
1992-01-31
LATEST ACTION
2020-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ASACOLDiscontinued
MESALAMINE 400MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2020-10-01Labeling · Supplement 28 · standard — Label ↗AP
2017-07-27Labeling · Supplement 27 · standard — Letter ↗AP
2015-09-16Manufacturing (CMC) · Supplement 26 · priorityAP
2015-05-27Efficacy · Supplement 25 · standard — Label ↗AP
2013-10-18Efficacy · Supplement 24 · standard — Label ↗AP
2010-05-24Labeling · Supplement 23 · unknown — Label ↗AP
2009-09-14Labeling · Supplement 20 · standard — Letter ↗AP
2007-04-10Labeling · Supplement 16 · standard — Letter ↗AP
2000-09-05Manufacturing (CMC) · Supplement 13 · priorityAP
2000-08-14Labeling · Supplement 10 · standardAP
2000-08-14Labeling · Supplement 11 · standardAP
2000-04-25Manufacturing (CMC) · Supplement 12 · priorityAP
1997-08-19Efficacy · Supplement 5 · standard — Review ↗AP
1997-07-08Manufacturing (CMC) · Supplement 9 · priorityAP
1997-01-31Manufacturing (CMC) · Supplement 8 · priorityAP
1996-11-25Manufacturing (CMC) · Supplement 7 · priorityAP
1996-08-30Labeling · Supplement 6 · standardAP
1996-05-06Manufacturing (CMC) · Supplement 3 · priorityAP
1996-05-06Manufacturing (CMC) · Supplement 4 · priorityAP
1995-11-26Manufacturing (CMC) · Supplement 2 · priorityAP
1993-05-27Labeling · Supplement 1 · standardAP
1992-01-31Type 3 - New Dosage Form · Original · priorityAP
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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