PRAVACHOL · ReferenceDiscontinued
PRAVASTATIN SODIUM 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRAVACHOL · ReferenceDiscontinued
PRAVASTATIN SODIUM 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRAVACHOL · ReferenceDiscontinued
PRAVASTATIN SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRAVACHOL · ReferenceDiscontinued
PRAVASTATIN SODIUM 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
2022-05-31Labeling · Supplement 70 · standard — Letter ↗AP 2020-09-25Labeling · Supplement 69 · 901 required — Letter ↗AP 2017-01-23Manufacturing (CMC) · Supplement 67 · standardAP
2016-07-05Labeling · Supplement 66 · standard — Label ↗AP 2013-05-29Manufacturing (CMC) · Supplement 65 · standardAP
2012-10-31Labeling · Supplement 63 · 901 required — Letter ↗AP 2012-10-31Labeling · Supplement 64 · standard — Letter ↗AP 2012-02-28Labeling · Supplement 62 · unknown — Label ↗AP 2011-05-18Labeling · Supplement 61 · standard — Label ↗AP 2007-02-28Efficacy · Supplement 60 · unknown — Label ↗AP 2005-07-06Labeling · Supplement 58 · standard — Label ↗AP 2003-09-05Labeling · Supplement 54 · standard — Review ↗AP 2002-10-29Efficacy · Supplement 52 · priority — Letter ↗AP 2002-07-12Labeling · Supplement 50 · standard — Label ↗AP 2002-06-14Manufacturing (CMC) · Supplement 51 · standard — Review ↗AP 2002-01-14Manufacturing (CMC) · Supplement 49 · standard — Review ↗AP 2001-12-18Efficacy · Supplement 46 · standard — Letter ↗AP 2001-08-13Manufacturing (CMC) · Supplement 45 · standardAP
2001-06-15Efficacy · Supplement 42 · standard — Letter ↗AP 2001-03-14Manufacturing (CMC) · Supplement 44 · standard — Review ↗AP 2001-03-12Manufacturing (CMC) · Supplement 43 · standard — Review ↗AP 2000-08-24Manufacturing (CMC) · Supplement 41 · standard — Review ↗AP 2000-06-23Efficacy · Supplement 37 · standard — Review ↗AP 2000-06-09Efficacy · Supplement 31 · standard — Review ↗AP 2000-02-10Efficacy · Supplement 32 · unknown — Review ↗AP 2000-01-18Efficacy · Supplement 30 · standard — Letter ↗AP 2000-01-18Efficacy · Supplement 29 · standard — Letter ↗AP 2000-01-18Efficacy · Supplement 27 · standard — Letter ↗AP 2000-01-18Efficacy · Supplement 26 · standard — Letter ↗AP 1999-10-14Manufacturing (CMC) · Supplement 35 · standard — Review ↗AP 1999-10-14Efficacy · Supplement 34 · standard — Review ↗AP 1999-09-13Labeling · Supplement 36 · standard — Review ↗AP 1999-04-09Manufacturing (CMC) · Supplement 25 · standard — Review ↗AP 1999-02-11Manufacturing (CMC) · Supplement 23 · standard — Review ↗AP 1999-01-28Manufacturing (CMC) · Supplement 24 · standard — Review ↗AP 1998-10-26Manufacturing (CMC) · Supplement 22 · standardAP
1998-08-17Labeling · Supplement 21 · standardAP
1998-05-20Labeling · Supplement 19 · standardAP
1998-03-27Efficacy · Supplement 18 · unknown — Review ↗AP 1998-03-11Efficacy · Supplement 20 · standard — Review ↗AP Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.