NDA 20711, held by Glaxosmithkline. Bupropion Hydrochloride.
As of Nov 13, 2026, NDA 20711 (Zyban), held by Glaxosmithkline, was first approved by FDA on May 14, 1997, with 42 approved supplements and 0 published complete response letters.
| Feb 7, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Sep 10, 1999 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 10, 1999 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 14, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Zyban100MG · tablet, extended release;oral | Bupropion Hydrochloride | Discontinued |
| Zyban150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Bupropion Hydrochloride | DiscontinuedReference drug |
| Mar 9, 2021 | Supplement 52Labeling · Standard review | Approved | |
| Jul 19, 2019 | Supplement 48Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 47Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 46Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 45REMS | Approved | |
| Jun 1, 2016 | Supplement 44Labeling · Standard review | Approved | |
| Dec 24, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Aug 13, 2014 | Supplement 43Labeling · Standard review | Approved | |
| Mar 27, 2014 | Supplement 39Labeling · Standard review | Approved | |
| Jan 18, 2012 | Supplement 36Labeling · Standard review | Approved | |
| Aug 22, 2011 | Supplement 26Labeling · Standard review | Approved | |
| Aug 22, 2011 | Supplement 35Labeling | Approved | |
| Sep 20, 2010 | Supplement 31Labeling · Standard review | Approved | |
| Feb 26, 2010 | Supplement 34Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 33Labeling | Approved | |
| Jul 1, 2009 | Supplement 32Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 29Labeling · Standard review | Approved | |
| Mar 22, 2007 | Supplement 28Labeling · Standard review | Approved | |
| Nov 16, 2006 | Supplement 27Labeling · Standard review | Approved | |
| Apr 28, 2006 | Supplement 24Labeling · Standard review | Approved | |
| Mar 13, 2006 | Supplement 22Labeling · Standard review | Approved | |
| Jan 12, 2005 | Supplement 21Labeling · Standard review | Approved | |
| Nov 3, 2004 | Supplement 20Labeling · Standard review | Approved | |
| Nov 3, 2004 | Supplement 19Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 13Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 18Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 16Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 14Labeling · Standard review | Approved | |
| Feb 21, 2002 | Supplement 15Labeling · Standard review | Approved | |
| Feb 15, 2002 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 7, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2000 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 28, 2000 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 28, 2000 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 3, 2000 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1999 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 10, 1999 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 7, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 5, 1999 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 5, 1999 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 24, 1999 | Supplement 4Labeling · Standard review | Approved | |
| Feb 24, 1999 | Supplement 2Labeling · Standard review | Approved | |
| May 14, 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
