APPLICATION
ANDA076052
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-23
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SIMVASTATINDiscontinued
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINDiscontinued
SIMVASTATIN 10MG · TABLET · ORAL
SIMVASTATINDiscontinued
SIMVASTATIN 80MG · TABLET · ORAL
SIMVASTATINDiscontinued
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINDiscontinued
SIMVASTATIN 5MG · TABLET · ORAL
Approval history
2025-08-15Labeling · Supplement 49 · standardAP
2023-07-31Labeling · Supplement 48 · standardAP
2023-07-31Labeling · Supplement 44 · standardAP
2015-12-16Labeling · Supplement 40 · standardAP
2014-11-05Labeling · Supplement 38 · standardAP
2014-11-05Labeling · Supplement 39 · standardAP
2012-12-18Labeling · Supplement 37 · standardAP
2012-03-23Labeling · Supplement 34AP
2011-11-22Labeling · Supplement 32AP
2011-07-26Labeling · Supplement 31AP
2011-02-16Labeling · Supplement 29AP
2010-09-17Labeling · Supplement 26AP
2010-05-17Labeling · Supplement 23AP
2010-04-12Labeling · Supplement 21AP
2009-09-24Labeling · Supplement 17AP
2009-08-18Labeling · Supplement 14AP
2008-04-25Labeling · Supplement 11AP
2006-12-20Labeling · Supplement 5AP
2006-12-20Manufacturing (CMC) · Supplement 4AP
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.
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