NDA 21365, held by Abbvie. Escitalopram Oxalate.
As of Nov 14, 2026, NDA 21365 (Lexapro), held by Abbvie, was first approved by FDA on Nov 27, 2002, with 24 approved supplements and 0 published complete response letters.
| May 12, 2023 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2009 | Supplement 22Efficacy (new indication or use) | Approved | |
| Mar 19, 2009 | Supplement 21Efficacy (new indication or use) | Approved | |
| Dec 18, 2003 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2003 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 27, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LexaproEQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Escitalopram Oxalate | DiscontinuedReference drug |
| Apr 19, 2024 | Supplement 41Labeling · Standard review | Approved | |
| Aug 18, 2023 | Supplement 40Labeling · Standard review | Approved | |
| May 12, 2023 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Sep 20, 2021 | Supplement 38Labeling | Approved | |
| Aug 28, 2020 | Supplement 37Labeling · Standard review | Approved | |
| Jan 11, 2019 | Supplement 36Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 35Labeling | Approved | |
| Oct 31, 2014 | Supplement 32Labeling · Standard review | Approved | |
| Jul 8, 2014 | Supplement 33Labeling | Approved | |
| Dec 3, 2012 | Supplement 30Labeling · Standard review | Approved | |
| May 12, 2011 | Supplement 24Labeling · Standard review | Approved | |
| Mar 11, 2011 | Supplement 25Labeling | Approved | |
| Mar 19, 2009 | Supplement 22Efficacy (new indication or use) | Approved | |
| Mar 19, 2009 | Supplement 21Efficacy (new indication or use) | Approved | |
| Jan 30, 2009 | Supplement 23Labeling · Standard review | Approved | |
| Oct 11, 2008 | Supplement 19Labeling · Standard review | Approved | |
| Sep 18, 2008 | Supplement 18Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 16Labeling · Standard review | Approved | None posted |
| Feb 18, 2005 | Supplement 12Labeling · Standard review | Approved | |
| Jan 11, 2005 | Supplement 7Labeling · Standard review | Approved | |
| May 20, 2004 | Supplement 8Labeling · Standard review | Approved | |
| Apr 8, 2004 | Supplement 5 | Approved | None posted |
| Dec 18, 2003 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2003 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 27, 2002 | 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
