Lowers the risk of total mortality. NDA 19766, held by Organon. Simvastatin.
As of Nov 13, 2026, NDA 19766 (Zocor), held by Organon, was first approved by FDA on Dec 23, 1991, with 86 approved supplements and 0 published complete response letters.
ZOCOR is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
| Apr 16, 2003 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2002 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2002 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Nov 7, 2000 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Apr 27, 2000 | Supplement 40Efficacy (new indication or use) | Approved | |
| Nov 22, 1999 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 1999 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Aug 5, 1999 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 1998 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 1998 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 1998 | Supplement 27Efficacy (new indication or use) | Approved | |
| Oct 31, 1997 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 30, 1995 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 23, 1991 | Original applicationNew molecular entity · Standard review | Approved |
| Zocor5MG · tablet;oral | Simvastatin | RxReference drug |
| Zocor10MG · tablet;oral | Simvastatin | RxReference drug |
| Zocor20MG · tablet;oral | Simvastatin | RxReference drug |
| Zocor40MG · tablet;oral | Simvastatin | RxReference drug |
| Zocor80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Simvastatin | DiscontinuedReference drug |
| Aug 9, 2023 | Supplement 104Labeling · Standard review | Approved | |
| Mar 14, 2023 | Supplement 103Labeling · Standard review | Approved | |
| May 31, 2022 | Supplement 102Labeling · Standard review | Approved | |
| Mar 7, 2022 | Supplement 99Labeling · Standard review | Approved | |
| Sep 25, 2020 | Supplement 101Labeling | Approved | |
| Oct 4, 2019 | Supplement 100Labeling · Standard review | Approved | |
| Mar 1, 2019 | Supplement 92Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 98Labeling · Standard review | Approved | |
| Mar 1, 2016 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Feb 2, 2015 | Supplement 93Labeling · Standard review | Approved | |
| Feb 27, 2014 | Supplement 91Labeling · Standard review | Approved | |
| Oct 25, 2013 | Supplement 90Labeling · Standard review | Approved | |
| Nov 15, 2012 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Oct 31, 2012 | Supplement 87Labeling | Approved | |
| Oct 31, 2012 | Supplement 88Labeling | Approved | |
| Feb 28, 2012 | Supplement 85Labeling | Approved | |
| Oct 6, 2011 | Supplement 83Labeling | Approved | |
| Jun 10, 2011 | Supplement 79Labeling | Approved | |
| Jun 8, 2011 | Supplement 77Labeling · Standard review | Approved | |
| Jun 8, 2011 | Supplement 82Labeling | Approved | |
| Nov 4, 2010 | Supplement 81Labeling | Approved | |
| Apr 8, 2010 | Supplement 80Labeling | Approved | |
| Mar 2, 2010 | Supplement 78Labeling | Approved | |
| Jun 11, 2008 | Supplement 76Labeling · Standard review | Approved | |
| Nov 26, 2007 | Supplement 75Labeling · Standard review | Approved | |
| Jun 1, 2007 | Supplement 74Manufacturing | Approved | |
| Aug 31, 2005 | Supplement 69Labeling · Standard review | Approved | |
| May 17, 2005 | Supplement 70Labeling · Standard review | Approved | |
| Feb 24, 2004 | Supplement 67Labeling · Standard review | Approved | |
| Feb 24, 2004 | Supplement 68Labeling · Standard review | Approved | |
| Sep 17, 2003 | Supplement 65Labeling · Standard review | Approved | |
| Sep 17, 2003 | Supplement 66Labeling · Standard review | Approved | |
| Apr 16, 2003 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2002 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2002 | Supplement 51Labeling · Standard review | Approved | |
| May 6, 2002 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Mar 21, 2002 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Mar 21, 2002 | Supplement 54Manufacturing · Standard review | Approved | |
| Feb 22, 2002 | Supplement 55Manufacturing · Standard review | Approved | |
| Nov 14, 2001 | Supplement 53Labeling · Standard review | Approved | |
| Nov 14, 2001 | Supplement 45Labeling · Standard review | Approved | |
| Sep 13, 2001 | Supplement 50Manufacturing · Standard review | Approved | |
| Jun 4, 2001 | Supplement 49Manufacturing · Standard review | Approved | |
| Apr 10, 2001 | Supplement 48Manufacturing · Standard review | Approved | |
| Apr 10, 2001 | Supplement 47Manufacturing · Standard review | Approved | |
| Dec 11, 2000 | Supplement 44Manufacturing · Standard review | Approved | |
| Nov 7, 2000 | Supplement 42Efficacy (new indication or use) | Approved | None posted |
| Aug 22, 2000 | Supplement 39Labeling · Standard review | Approved | None posted |
| Apr 27, 2000 | Supplement 40Efficacy (new indication or use) | Approved | |
| Apr 14, 2000 | Supplement 43Manufacturing · Standard review | Approved | |
| Mar 15, 2000 | Supplement 41Manufacturing · Standard review | Approved | |
| Nov 22, 1999 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 1999 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 1999 | Supplement 35Labeling · Standard review | Approved | |
| Aug 5, 1999 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Apr 23, 1999 | Supplement 31Labeling · Standard review | Approved | |
| Mar 22, 1999 | Supplement 33Manufacturing · Standard review | Approved | |
| Sep 24, 1998 | Supplement 30Manufacturing · Standard review | Approved | |
| Jul 10, 1998 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 1998 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Jun 29, 1998 | Supplement 29Labeling · Standard review | Approved | |
| Mar 31, 1998 | Supplement 27Efficacy (new indication or use) | Approved | |
| Dec 2, 1997 | Supplement 25Manufacturing · Standard review | Approved | |
| Oct 31, 1997 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 9, 1997 | Supplement 23Manufacturing · Standard review | Approved | |
| Aug 12, 1997 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jul 18, 1997 | Supplement 22Manufacturing · Standard review | Approved | |
| May 23, 1997 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 19, 1997 | Supplement 18Labeling · Standard review | Approved | |
| Mar 17, 1997 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 22, 1996 | Supplement 16Manufacturing · Standard review | Approved | |
| Nov 6, 1995 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1995 | Supplement 12Manufacturing · Standard review | Approved | |
| Aug 1, 1995 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jun 30, 1995 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 9, 1995 | Supplement 14Labeling · Standard review | Approved | |
| Apr 19, 1995 | Supplement 8Labeling · Standard review | Approved | |
| Feb 16, 1995 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 23, 1995 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 21, 1994 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 28, 1994 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1994 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 22, 1994 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 24, 1993 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1993 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1992 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 23, 1991 | 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
