NDA 204412, held by Abbvie. Mesalamine.
As of Nov 14, 2026, NDA 204412 (Delzicol), held by Abbvie, was first approved by FDA on Feb 1, 2013, with 12 approved supplements and 0 published complete response letters.
| Sep 9, 2015 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2013 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Delzicol400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed release;oral | Mesalamine | DiscontinuedReference drug |
| Oct 24, 2023 | Supplement 17Labeling · Standard review | Approved | |
| Nov 16, 2022 | Supplement 16Labeling · Standard review | Approved | |
| Nov 1, 2021 | Supplement 15Labeling · Standard review | Approved | |
| Oct 1, 2020 | Supplement 12Labeling · Standard review | Approved | |
| May 21, 2020 | Supplement 11Manufacturing · Standard review | Approved | |
| Jul 27, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Sep 9, 2015 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 2, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 27, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Apr 28, 2014 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2013 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 1, 2013 | Original applicationNew dosage form · Priority 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
