NDA 19898, held by Bristol Myers Squibb. Pravastatin Sodium.
As of Nov 14, 2026, NDA 19898 (Pravachol), held by Bristol Myers Squibb, was first approved by FDA on Oct 31, 1991, with 56 approved supplements and 0 published complete response letters.
| Feb 28, 2007 | Supplement 60Efficacy (new indication or use) | Approved | |
| Oct 29, 2002 | Supplement 52Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 2001 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2001 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Jun 23, 2000 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2000 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Feb 10, 2000 | Supplement 32Efficacy (new indication or use) | Approved | |
| Jan 18, 2000 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 1999 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Mar 27, 1998 | Supplement 18Efficacy (new indication or use) | Approved | |
| Mar 11, 1998 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Jul 2, 1996 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Mar 22, 1996 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | None posted |
| Oct 31, 1991 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Pravachol10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pravastatin Sodium | DiscontinuedReference drug |
| Pravachol20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pravastatin Sodium | DiscontinuedReference drug |
| Pravachol40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pravastatin Sodium | DiscontinuedReference drug |
| Pravachol80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Pravastatin Sodium | DiscontinuedReference drug |
| May 31, 2022 | Supplement 70Labeling · Standard review | Approved | |
| Sep 25, 2020 | Supplement 69Labeling | Approved | |
| Jan 23, 2017 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jul 5, 2016 | Supplement 66Labeling · Standard review | Approved | |
| May 29, 2013 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Oct 31, 2012 | Supplement 63Labeling | Approved | |
| Oct 31, 2012 | Supplement 64Labeling · Standard review | Approved | |
| Feb 28, 2012 | Supplement 62Labeling | Approved | |
| May 18, 2011 | Supplement 61Labeling · Standard review | Approved | |
| Feb 28, 2007 | Supplement 60Efficacy (new indication or use) | Approved | |
| Jul 6, 2005 | Supplement 58Labeling · Standard review | Approved | |
| Sep 5, 2003 | Supplement 54Labeling · Standard review | Approved | |
| Oct 29, 2002 | Supplement 52Efficacy (new indication or use) · Priority review | Approved | |
| Jul 12, 2002 | Supplement 50Labeling · Standard review | Approved | |
| Jun 14, 2002 | Supplement 51Manufacturing · Standard review | Approved | |
| Jan 14, 2002 | Supplement 49Manufacturing · Standard review | Approved | |
| Dec 18, 2001 | Supplement 46Efficacy (new indication or use) · Standard review | Approved | |
| Aug 13, 2001 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 15, 2001 | Supplement 42Efficacy (new indication or use) · Standard review | Approved | |
| Mar 14, 2001 | Supplement 44Manufacturing · Standard review | Approved | |
| Mar 12, 2001 | Supplement 43Manufacturing · Standard review | Approved | |
| Aug 24, 2000 | Supplement 41Manufacturing · Standard review | Approved | |
| Jun 23, 2000 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2000 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Feb 10, 2000 | Supplement 32Efficacy (new indication or use) | Approved | |
| Jan 18, 2000 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2000 | Supplement 26Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 1999 | Supplement 34Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 1999 | Supplement 35Manufacturing · Standard review | Approved | |
| Sep 13, 1999 | Supplement 36Labeling · Standard review | Approved | |
| Apr 9, 1999 | Supplement 25Manufacturing · Standard review | Approved | |
| Feb 11, 1999 | Supplement 23Manufacturing · Standard review | Approved | |
| Jan 28, 1999 | Supplement 24Manufacturing · Standard review | Approved | |
| Oct 26, 1998 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 17, 1998 | Supplement 21Labeling · Standard review | Approved | None posted |
| May 20, 1998 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 27, 1998 | Supplement 18Efficacy (new indication or use) | Approved | |
| Mar 11, 1998 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 1997 | Supplement 17Labeling · Standard review | Approved | |
| Jul 2, 1996 | Supplement 15Efficacy (new indication or use) | Approved | None posted |
| Apr 30, 1996 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1996 | Supplement 16Manufacturing · Standard review | Approved | |
| Mar 22, 1996 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | None posted |
| Feb 28, 1996 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1995 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 28, 1994 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 2, 1994 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 9, 1994 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1994 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jul 23, 1993 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1993 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1993 | Supplement 3Labeling | Approved | None posted |
| Jul 7, 1992 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 18, 1992 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1991 | Original applicationNew molecular entity · 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
