NDA 21830, held by Abbvie. Mesalamine.
As of Nov 14, 2026, NDA 21830 (Asacol Hd), held by Abbvie, was first approved by FDA on May 29, 2008, with 12 approved supplements and 0 published complete response letters.
| Oct 18, 2013 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 29, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Asacol Hd800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, delayed release;oral | Mesalamine | DiscontinuedReference drug |
| Nov 16, 2022 | Supplement 20Labeling · Standard review | Approved | |
| Nov 1, 2021 | Supplement 19Labeling · Standard review | Approved | |
| Oct 1, 2020 | Supplement 16Labeling · Standard review | Approved | |
| May 21, 2020 | Supplement 15Manufacturing · Standard review | Approved | |
| Apr 18, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Jul 27, 2017 | Supplement 11Labeling · Standard review | Approved | |
| May 5, 2016 | Supplement 10Labeling · Standard review | Approved | |
| Oct 22, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 13, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2010 | Supplement 5Labeling | Approved | |
| Apr 23, 2009 | Supplement 2Labeling · Standard review | Approved | |
| May 29, 2008 | Original applicationNew dosage form · Standard review | Approved |
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
