NDA 20699, held by Upjohn. Venlafaxine Hydrochloride.
As of Nov 13, 2026, NDA 20699 (Effexor Xr), held by Upjohn, was first approved by FDA on Oct 20, 1997, with 79 approved supplements and 0 published complete response letters.
Effexor XR is indicated in adults for the treatment of:
| Dec 14, 2007 | Supplement 47Efficacy (new indication or use) | Approved | |
| Dec 1, 2005 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2005 | Supplement 54Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2005 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| May 5, 2004 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Feb 11, 2003 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jul 13, 2000 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Effexor XrEQ 37.5MG BASE · capsule, extended release;oral | Venlafaxine Hydrochloride | RxReference drug |
| Effexor XrEQ 75MG BASE · capsule, extended release;oral | Venlafaxine Hydrochloride | RxReference drug |
| Effexor XrEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| Effexor XrEQ 150MG BASE · capsule, extended release;oral | Venlafaxine Hydrochloride | RxReference drug |
| Aug 18, 2023 | Supplement 118Labeling · Standard review | Approved | |
| Aug 15, 2022 | Supplement 112Labeling · Standard review | Approved | |
| Nov 10, 2021 | Supplement 113Labeling · Standard review | Approved | |
| Sep 20, 2021 | Supplement 114Labeling | Approved | |
| Dec 19, 2017 | Supplement 110Labeling · Standard review | Approved | |
| Dec 19, 2017 | Supplement 111Labeling | Approved | |
| Mar 29, 2017 | Supplement 108Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 107Labeling | Approved | |
| Feb 29, 2016 | Supplement 106Labeling · Standard review | Approved | |
| Dec 17, 2014 | Supplement 91Labeling · Standard review | Approved | |
| Oct 21, 2014 | Supplement 104Labeling · Standard review | Approved | |
| Jul 7, 2014 | Supplement 103Labeling · Standard review | Approved | |
| Jul 7, 2014 | Supplement 105Labeling | Approved | |
| Dec 18, 2012 | Supplement 99Labeling | Approved | |
| Dec 18, 2012 | Supplement 102Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 49Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 89Labeling · Standard review | Approved | |
| May 3, 2012 | Supplement 100Labeling · Standard review | Approved | |
| Jan 6, 2010 | Supplement 90Labeling · Standard review | Approved | |
| Nov 9, 2009 | Supplement 86Labeling · Standard review | Approved | |
| Jan 30, 2009 | Supplement 87Labeling · Standard review | Approved | |
| May 23, 2008 | Supplement 81Labeling · Standard review | Approved | |
| Feb 11, 2008 | Supplement 83Labeling · Standard review | Approved | |
| Feb 7, 2008 | Supplement 80Labeling · Standard review | Approved | None posted |
| Jan 30, 2008 | Supplement 67Labeling · Standard review | Approved | |
| Dec 14, 2007 | Supplement 47Efficacy (new indication or use) | Approved | |
| Sep 20, 2007 | Supplement 77Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 79Labeling · Standard review | Approved | |
| Aug 1, 2007 | Supplement 55Labeling · Standard review | Approved | |
| Aug 1, 2007 | Supplement 75Labeling · Standard review | Approved | |
| Feb 7, 2007 | Supplement 69Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 72Labeling · Standard review | Approved | |
| Sep 14, 2006 | Supplement 71Labeling · Standard review | Approved | |
| Mar 2, 2006 | Supplement 66Manufacturing | Approved | |
| Feb 24, 2006 | Supplement 56Labeling · Standard review | Approved | |
| Jan 12, 2006 | Supplement 62Labeling · Standard review | Approved | |
| Jan 12, 2006 | Supplement 64Labeling · Standard review | Approved | |
| Dec 1, 2005 | Supplement 59Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2005 | Supplement 54Efficacy (new indication or use) · Standard review | Approved | |
| Nov 18, 2005 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Feb 18, 2005 | Supplement 58Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 41Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 48Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 52Labeling · Standard review | Approved | |
| May 5, 2004 | Supplement 30Efficacy (new indication or use) · Priority review | Approved | |
| Apr 8, 2004 | Supplement 46Labeling · Standard review | Approved | |
| Mar 19, 2004 | Supplement 50Labeling · Standard review | Approved | |
| Mar 19, 2004 | Supplement 39Labeling · Standard review | Approved | |
| Mar 16, 2004 | Supplement 45Labeling · Standard review | Approved | |
| Sep 2, 2003 | Supplement 43Labeling · Standard review | Approved | |
| Sep 2, 2003 | Supplement 38Labeling · Standard review | Approved | |
| Feb 26, 2003 | Supplement 32Labeling · Standard review | Approved | |
| Feb 11, 2003 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2003 | Supplement 14 | Approved | |
| Jan 31, 2003 | Supplement 18 | Approved | |
| Jan 31, 2003 | Supplement 21 | Approved | |
| Jan 31, 2003 | Supplement 23 | Approved | |
| Jan 31, 2003 | Supplement 26 | Approved | |
| Jan 31, 2003 | Supplement 27 | Approved | |
| Jan 31, 2003 | Supplement 34Labeling · Standard review | Approved | |
| Nov 19, 2002 | Supplement 28Manufacturing · Standard review | Approved | |
| Oct 22, 2002 | Supplement 29Labeling · Standard review | Approved | |
| Aug 7, 2002 | Supplement 25Manufacturing · Standard review | Approved | |
| Oct 23, 2001 | Supplement 24Manufacturing · Standard review | Approved | |
| Aug 22, 2001 | Supplement 5Manufacturing · Standard review | Approved | |
| May 2, 2001 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2000 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 31, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 20, 2000 | Supplement 13Manufacturing · Standard review | Approved | |
| Jul 13, 2000 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 12, 2000 | Supplement 12Labeling · Standard review | Approved | |
| Mar 9, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2000 | Supplement 10Manufacturing · Standard review | Approved | |
| Mar 3, 2000 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 25, 2000 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 8, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1997 | 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
