Apriso

As of Nov 13, 2026, NDA 22301 (Apriso), held by Salix, was first approved by FDA on Oct 31, 2008, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2008
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

APRISO is indicated for the maintenance of remission of ulcerative colitis in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 31, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Apriso375MG · capsule, extended release;oral	Mesalamine	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 24, 2023	Supplement 22Labeling · Standard review	Approved	Label
Nov 16, 2022	Supplement 21Labeling · Standard review	Approved	Letter Label
Nov 1, 2021	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 1, 2020	Supplement 15Labeling · Standard review	Approved	Label Letter
Mar 12, 2019	Supplement 14Labeling · Standard review	Approved	Label
Jul 27, 2017	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 21, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 26, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 25, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 31, 2008	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22301
Drugs@FDA: Overview at FDA
Company: Salix Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters