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FDA NDA · NDA021252

CANASA

mesalamine

Sponsor: ABBVIE

APPLICATION
NDA021252
TYPE
NDA
ORIGINAL APPROVAL
2001-01-05
LATEST ACTION
2023-10-24
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued, Prescription

Products

CANASADiscontinued
MESALAMINE 500MG · SUPPOSITORY · RECTAL
CANASA · ReferencePrescription
MESALAMINE 1GM · SUPPOSITORY · RECTAL

Approval history

2023-10-24Labeling · Supplement 30 · standard — Label ↗AP
2022-11-16Labeling · Supplement 29 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 28 · standard — Letter ↗AP
2020-10-01Labeling · Supplement 25 · standard — Letter ↗AP
2017-07-27Labeling · Supplement 23 · standard — Label ↗AP
2016-09-02Efficacy · Supplement 14 · priority — Label ↗AP
2014-07-30Manufacturing (CMC) · Supplement 21 · priorityAP
2014-01-02Manufacturing (CMC) · Supplement 19 · priorityAP
2013-12-24Manufacturing (CMC) · Supplement 18 · priorityAP
2013-12-17Labeling · Supplement 20 · standard — Label ↗AP
2013-05-03Manufacturing (CMC) · Supplement 16 · priorityAP
2013-02-06Labeling · Supplement 13 · unknown — Label ↗AP
2008-05-23Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2006-06-08Labeling · Supplement 7 · standard — Letter ↗AP
2004-11-05Efficacy · Supplement 5 · standard — Letter ↗AP
2004-09-23Labeling · Supplement 6 · standard — Letter ↗AP
2003-10-14Labeling · Supplement 2 · standard — Letter ↗AP
2001-01-05Type 5 - New Formulation or New Manufacturer · Original · priority — Letter ↗AP
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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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