Treats major depressive disorder (MDD). NDA 20358, held by Glaxosmithkline. Bupropion Hydrochloride.
As of Nov 13, 2026, NDA 20358 (Wellbutrin Sr), held by Glaxosmithkline, was first approved by FDA on Oct 4, 1996, with 59 approved supplements and 0 published complete response letters.
WELLBUTRIN SR (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD. The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2001 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Wellbutrin Sr50MG · tablet, extended release;oral | Bupropion Hydrochloride | Discontinued |
| Wellbutrin Sr100MG · tablet, extended release;oral | Bupropion Hydrochloride | RxReference drug |
| Wellbutrin Sr150MG · tablet, extended release;oral | Bupropion Hydrochloride | RxReference drug |
| Wellbutrin Sr200MG · tablet, extended release;oral | Bupropion Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2025 | Supplement 70Labeling · Standard review | Approved | |
| May 7, 2024 | Supplement 68Labeling · Standard review | Approved | |
| Dec 6, 2022 | Supplement 66Labeling · Standard review | Approved | |
| Oct 20, 2020 | Supplement 64Labeling · Standard review | Approved | |
| Nov 5, 2019 | Supplement 61Labeling · Standard review | Approved | |
| Aug 11, 2017 | Supplement 60Labeling · Standard review | Approved | |
| May 10, 2017 | Supplement 58Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 59Labeling · Standard review | Approved | |
| Apr 25, 2016 | Supplement 57Labeling · Standard review | Approved | |
| Dec 16, 2014 | Supplement 55Labeling · Standard review | Approved | |
| Jul 17, 2014 | Supplement 56Labeling | Approved | |
| Dec 23, 2013 | Supplement 53Labeling · Standard review | Approved | |
| Dec 23, 2013 | Supplement 54Labeling · Standard review | Approved | |
| Mar 19, 2013 | Supplement 52Labeling · Standard review | Approved | |
| Aug 2, 2012 | Supplement 51REMS | Approved | |
| Jul 25, 2011 | Supplement 50Labeling · Standard review | Approved | |
| May 17, 2011 | Supplement 39Labeling · Standard review | Approved | |
| May 17, 2011 | Supplement 49Labeling · Standard review | Approved | |
| May 25, 2010 | Supplement 45Labeling · Standard review | Approved | |
| Feb 26, 2010 | Supplement 48Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 46Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 47Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 43Labeling · Standard review | Approved | |
| Jan 29, 2007 | Supplement 42Labeling · Standard review | Approved | |
| Jul 3, 2006 | Supplement 37Labeling · Standard review | Approved | |
| Jul 3, 2006 | Supplement 40Labeling · Standard review | Approved | |
| Feb 28, 2006 | Supplement 35Labeling · Standard review | Approved | |
| Jan 12, 2005 | Supplement 34Labeling · Standard review | Approved | |
| May 27, 2004 | Supplement 32Labeling · Standard review | Approved | |
| Apr 26, 2004 | Supplement 30Labeling · Standard review | Approved | |
| Oct 22, 2002 | Supplement 29Labeling · Standard review | Approved | |
| Oct 2, 2002 | Supplement 24Labeling · Standard review | Approved | |
| Jul 12, 2002 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jul 12, 2002 | Supplement 28Manufacturing · Standard review | Approved | |
| Jun 20, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Jun 20, 2002 | Supplement 23Labeling · Standard review | Approved | |
| Jun 14, 2002 | Supplement 27Manufacturing · Standard review | Approved | |
| Feb 13, 2002 | Supplement 25Manufacturing · Standard review | Approved | |
| Jun 11, 2001 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Oct 11, 2000 | Supplement 20Manufacturing · Standard review | Approved | |
| Oct 11, 2000 | Supplement 21Manufacturing · Standard review | Approved | |
| Oct 11, 2000 | Supplement 22Manufacturing · Standard review | Approved | |
| Aug 4, 2000 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 6, 1999 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1999 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 26, 1999 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 30, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 30, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1997 | Supplement 1Labeling · Standard review | Approved | |
| Dec 16, 1997 | Supplement 3Labeling · Standard review | Approved | |
| Oct 4, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
