Canasa

Treats mildly to moderately active ulcerative proctitis. NDA 21252, held by Abbvie. Mesalamine.

As of Nov 14, 2026, NDA 21252 (Canasa), held by Abbvie, was first approved by FDA on Jan 5, 2001, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 5, 2001
Review: Priority
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CANASA is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Sep 2, 2016	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 5, 2004	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 5, 2001	Original applicationNew formulation or manufacturer · Priority review	Approved	Label Letter Review Pediatric Medical Review

Products

2 strengths and forms


Canasa500MG · suppository;rectal	Mesalamine	Discontinued
Canasa1GM · suppository;rectal	Mesalamine	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 24, 2023	Supplement 30Labeling · Standard review	Approved	Label Letter
Nov 16, 2022	Supplement 29Labeling · Standard review	Approved	Letter Label
Nov 1, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 1, 2020	Supplement 25Labeling · Standard review	Approved	Label Letter
Jul 27, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 2, 2016	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 30, 2014	Supplement 21Manufacturing · Priority review	Approved	None posted
Jan 2, 2014	Supplement 19Manufacturing · Priority review	Approved	None posted
Dec 24, 2013	Supplement 18Manufacturing · Priority review	Approved	None posted
Dec 17, 2013	Supplement 20Labeling · Standard review	Approved	Letter Label
May 3, 2013	Supplement 16Manufacturing · Priority review	Approved	None posted
Feb 6, 2013	Supplement 13Labeling	Approved	Label Letter
May 23, 2008	Supplement 9Manufacturing	Approved	Letter
Jun 8, 2006	Supplement 7Labeling · Standard review	Approved	Letter
Nov 5, 2004	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 23, 2004	Supplement 6Labeling · Standard review	Approved	Letter
Oct 14, 2003	Supplement 2Labeling · Standard review	Approved	Letter
Jan 5, 2001	Original applicationNew formulation or manufacturer · Priority review	Approved	Label Letter Review Pediatric Medical Review

Identifiers

Application: NDA 21252
Drugs@FDA: Overview at FDA
Company: AbbVie

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