FDA NDA · NDA022301

MESALAMINE

Sponsor: SALIX

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
NDA022301
TYPE
NDA
ORIGINAL APPROVAL
2008-10-31
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

APRISO · ReferencePrescription
MESALAMINE 375MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-10-14Labeling · Supplement 25 · standard — Letter ↗AP
2023-10-24Labeling · Supplement 22 · standard — Label ↗AP
2022-11-16Labeling · Supplement 21 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 18 · standard — Letter ↗AP
2020-10-01Labeling · Supplement 15 · standard — Letter ↗AP
2019-03-12Labeling · Supplement 14 · standard — Label ↗AP
2017-07-27Labeling · Supplement 9 · standard — Label ↗AP
2016-12-21Manufacturing (CMC) · Supplement 7 · standardAP
2016-01-26Manufacturing (CMC) · Supplement 6 · standardAP
2013-10-25Manufacturing (CMC) · Supplement 4 · standardAP
2008-10-31Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →