NDA 21427, held by Lilly. Duloxetine Hydrochloride.
As of Nov 15, 2026, NDA 21427 (Cymbalta), held by Lilly, was first approved by FDA on Aug 3, 2004, with 37 approved supplements and 0 published complete response letters.
| Apr 20, 2020 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2014 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2014 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2012 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Nov 19, 2009 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2007 | Supplement 15Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Supplement 11Efficacy (new indication or use) | Approved | |
| Aug 3, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| CymbaltaEQ 20MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | DiscontinuedReference drug |
| CymbaltaEQ 30MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | DiscontinuedReference drug |
| CymbaltaEQ 60MG BASE · capsule, delayed rel pellets;oral | Duloxetine Hydrochloride | DiscontinuedReference drug |
| Aug 18, 2023 | Supplement 57Labeling · Standard review | Approved | |
| Aug 18, 2023 | Supplement 55Labeling · Standard review | Approved | |
| Sep 20, 2021 | Supplement 56Labeling | Approved | |
| Oct 1, 2020 | Supplement 53Labeling · Standard review | Approved | |
| Apr 20, 2020 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 2019 | Supplement 51Labeling · Standard review | Approved | |
| Dec 19, 2017 | Supplement 50Labeling | Approved | |
| Jan 4, 2017 | Supplement 49Labeling | Approved | |
| Sep 2, 2016 | Supplement 48Labeling | Approved | |
| Jul 12, 2016 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jun 18, 2015 | Supplement 46Labeling · Standard review | Approved | |
| Nov 25, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Nov 25, 2014 | Supplement 37Labeling · Standard review | Approved | |
| Oct 16, 2014 | Supplement 44Efficacy (new indication or use) · Standard review | Approved | |
| Oct 16, 2014 | Supplement 43Efficacy (new indication or use) · Standard review | Approved | |
| Jul 17, 2014 | Supplement 45Labeling | Approved | |
| Oct 18, 2012 | Supplement 41Efficacy (new indication or use) · Priority review | Approved | |
| Oct 18, 2012 | Supplement 40Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 38Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 32Labeling · Standard review | Approved | |
| Sep 2, 2011 | Supplement 39Labeling | Approved | |
| Apr 12, 2011 | Supplement 36Labeling · Standard review | Approved | |
| Mar 4, 2011 | Supplement 31Labeling · Standard review | Approved | |
| Nov 19, 2009 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Mar 18, 2009 | Supplement 28Labeling · Standard review | Approved | |
| Mar 18, 2009 | Supplement 27Labeling · Standard review | Approved | |
| Mar 18, 2009 | Supplement 21Labeling · Standard review | Approved | |
| Jan 30, 2009 | Supplement 29Labeling | Approved | |
| Nov 28, 2007 | Supplement 17Labeling · Standard review | Approved | |
| Nov 28, 2007 | Supplement 15Efficacy (new indication or use) | Approved | |
| Aug 2, 2007 | Supplement 18Labeling · Standard review | Approved | |
| Feb 23, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Feb 23, 2007 | Supplement 11Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Supplement 9Labeling · Standard review | Approved | |
| Sep 20, 2006 | Supplement 12Labeling · Standard review | Approved | |
| Jun 6, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Aug 3, 2004 | Original applicationNew molecular entity · 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
