NDA 19643, held by Merck. Lovastatin.
As of Nov 13, 2026, NDA 19643 (Mevacor), held by Merck, was first approved by FDA on Aug 31, 1987, with 73 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2005 | Supplement 75Efficacy (new indication or use) · Standard review | Approved | |
| Feb 14, 2002 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 1999 | Supplement 55Efficacy (new indication or use) · Standard review | Approved | |
| May 3, 1995 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 8, 1995 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | None posted |
| Mar 28, 1991 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Aug 31, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mevacor10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Lovastatin | DiscontinuedReference drug |
| Mevacor20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Lovastatin | DiscontinuedReference drug |
| Mevacor40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Lovastatin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2014 | Supplement 88Labeling · Standard review | Approved | |
| Oct 31, 2012 | Supplement 86Labeling · Standard review | Approved | |
| Oct 31, 2012 | Supplement 87Labeling | Approved | |
| Feb 28, 2012 | Supplement 85Labeling | Approved | |
| Jun 10, 2011 | Supplement 82Labeling | Approved | |
| Feb 2, 2011 | Supplement 84Labeling | Approved | |
| Jun 30, 2010 | Supplement 81Labeling | Approved | |
| Mar 9, 2009 | Supplement 80Manufacturing | Approved | |
| Dec 7, 2007 | Supplement 79Manufacturing | Approved | |
| May 29, 2007 | Supplement 78Labeling · Standard review | Approved | |
| Apr 17, 2007 | Supplement 61Labeling · Standard review | Approved | |
| Nov 4, 2005 | Supplement 76Labeling · Standard review | Approved | |
| Jun 13, 2005 | Supplement 77Labeling · Standard review | Approved | |
| Apr 7, 2005 | Supplement 75Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2003 | Supplement 73 | Approved | |
| Sep 23, 2002 | Supplement 70Manufacturing · Priority review | Approved | None posted |
| Sep 20, 2002 | Supplement 71Labeling · Standard review | Approved | |
| Feb 14, 2002 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2002 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Oct 22, 2001 | Supplement 69Labeling · Standard review | Approved | |
| Aug 1, 2001 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Jun 26, 2001 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Apr 26, 2001 | Supplement 62Labeling · Standard review | Approved | |
| Apr 26, 2001 | Supplement 64Labeling · Standard review | Approved | |
| Sep 14, 2000 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| Aug 22, 2000 | Supplement 59Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 55Efficacy (new indication or use) · Standard review | Approved | |
| Mar 1, 1999 | Supplement 57Labeling · Standard review | Approved | None posted |
| Aug 28, 1998 | Supplement 56Labeling · Standard review | Approved | None posted |
| Jun 29, 1998 | Supplement 54Labeling · Standard review | Approved | None posted |
| Apr 22, 1998 | Supplement 53Labeling · Standard review | Approved | |
| Nov 20, 1997 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Aug 12, 1997 | Supplement 50Labeling · Standard review | Approved | |
| Jun 25, 1997 | Supplement 51Manufacturing · Priority review | Approved | |
| Mar 27, 1997 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Feb 6, 1997 | Supplement 47Labeling · Standard review | Approved | None posted |
| Dec 26, 1996 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Apr 30, 1996 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Feb 9, 1996 | Supplement 40Labeling · Standard review | Approved | None posted |
| Aug 8, 1995 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Aug 8, 1995 | Supplement 44Labeling · Standard review | Approved | None posted |
| Aug 1, 1995 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| May 3, 1995 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 8, 1995 | Supplement 34Efficacy (new indication or use) · Priority review | Approved | None posted |
| Jan 23, 1995 | Supplement 41Labeling · Standard review | Approved | None posted |
| Dec 21, 1994 | Supplement 37Labeling · Standard review | Approved | None posted |
| Dec 20, 1994 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Jul 5, 1994 | Supplement 36Labeling · Standard review | Approved | None posted |
| May 17, 1994 | Supplement 32Labeling · Standard review | Approved | None posted |
| May 17, 1994 | Supplement 33Labeling · Standard review | Approved | None posted |
| Nov 24, 1993 | Supplement 27Labeling | Approved | None posted |
| Nov 23, 1993 | Supplement 28Labeling | Approved | None posted |
| Nov 22, 1993 | Supplement 21Labeling | Approved | None posted |
| Aug 9, 1993 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Dec 17, 1992 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Nov 27, 1992 | Supplement 30Labeling · Standard review | Approved | None posted |
| Apr 15, 1992 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Dec 19, 1991 | Supplement 17Labeling | Approved | |
| Nov 27, 1991 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1991 | Supplement 20Labeling | Approved | None posted |
| Aug 28, 1991 | Supplement 12Labeling | Approved | None posted |
| Apr 10, 1991 | Supplement 15Labeling | Approved | None posted |
| Mar 28, 1991 | Supplement 18Efficacy (new indication or use) | Approved | None posted |
| Mar 12, 1991 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Feb 21, 1991 | Supplement 10Labeling | Approved | None posted |
| Oct 20, 1989 | Supplement 11Labeling | Approved | None posted |
| Mar 21, 1989 | Supplement 7Labeling | Approved | None posted |
| Dec 20, 1988 | Supplement 8Labeling | Approved | None posted |
| Dec 14, 1988 | Supplement 9Labeling | Approved | None posted |
| Nov 22, 1988 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jul 6, 1988 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Mar 3, 1988 | Supplement 4Labeling | Approved | None posted |
| Mar 1, 1988 | Supplement 1Labeling | Approved | None posted |
| Aug 31, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
