Asacol

NDA 19651, held by Apil. Mesalamine.

As of Nov 14, 2026, NDA 19651 (Asacol), held by Apil, was first approved by FDA on Jan 31, 1992, with 21 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1992
Review: Priority
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


May 27, 2015	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2013	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 19, 1997	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Jan 31, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Asacol400MG · tablet, delayed release;oral	Mesalamine	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Oct 1, 2020	Supplement 28Labeling · Standard review	Approved	Label Letter
Jul 27, 2017	Supplement 27Labeling · Standard review	Approved	Letter Label
Sep 16, 2015	Supplement 26Manufacturing · Priority review	Approved	None posted
May 27, 2015	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 18, 2013	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 24, 2010	Supplement 23Labeling	Approved	Letter Label
Sep 14, 2009	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 10, 2007	Supplement 16Labeling · Standard review	Approved	Letter
Sep 5, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Aug 14, 2000	Supplement 11Labeling · Standard review	Approved	None posted
Aug 14, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Apr 25, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 19, 1997	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review
Jul 8, 1997	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 31, 1997	Supplement 8Manufacturing · Priority review	Approved	None posted
Nov 25, 1996	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 30, 1996	Supplement 6Labeling · Standard review	Approved	None posted
May 6, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
May 6, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 26, 1995	Supplement 2Manufacturing · Priority review	Approved	None posted
May 27, 1993	Supplement 1Labeling · Standard review	Approved	None posted
Jan 31, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 19651
Drugs@FDA: Overview at FDA
Company: APIL

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