NDA 21689, held by Astrazeneca. Esomeprazole Sodium.
As of Nov 14, 2026, NDA 21689 (Nexium Iv), held by Astrazeneca, was first approved by FDA on Mar 31, 2005, with 28 approved supplements and 0 published complete response letters.
| Mar 4, 2014 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Apr 29, 2011 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Nexium IvEQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Esomeprazole Sodium | DiscontinuedReference drug |
| Nexium IvEQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Esomeprazole Sodium | DiscontinuedReference drug |
| Jul 18, 2023 | Supplement 38Labeling · Standard review | Approved | |
| Mar 4, 2022 | Supplement 37Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 35Labeling · Standard review | Approved | |
| Sep 30, 2019 | Supplement 34Labeling · Standard review | Approved | |
| Aug 10, 2018 | Supplement 33Labeling · Standard review | Approved | |
| Dec 19, 2016 | Supplement 31Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 32Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 30Labeling | Approved | |
| Oct 20, 2014 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2014 | Supplement 27Labeling · Standard review | Approved | |
| Mar 4, 2014 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Feb 25, 2014 | Supplement 28Labeling | Approved | |
| Oct 9, 2012 | Supplement 25Labeling · Standard review | Approved | |
| Sep 28, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Jan 20, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Jun 30, 2011 | Supplement 20Labeling | Approved | |
| Jun 21, 2011 | Supplement 16Labeling | Approved | |
| Apr 29, 2011 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Sep 3, 2010 | Supplement 18Labeling | Approved | |
| Mar 4, 2010 | Supplement 15Labeling | Approved | |
| Jan 15, 2009 | Supplement 13Labeling · Standard review | Approved | |
| Jan 15, 2009 | Supplement 12Labeling · Standard review | Approved | |
| Apr 27, 2007 | Supplement 11Labeling · Standard review | Approved | |
| Apr 27, 2007 | Supplement 8Labeling · Standard review | Approved | |
| Sep 26, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Sep 15, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Feb 16, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Jan 12, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Mar 31, 2005 | 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
