APPLICATION
ANDA078155
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-26
LATEST ACTION
2025-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
Approval history
2025-03-03Labeling · Supplement 41 · standardAP
2023-07-31Labeling · Supplement 39 · standardAP
2022-10-13Labeling · Supplement 38 · standardAP
2022-10-13Labeling · Supplement 36 · standardAP
2020-06-23Labeling · Supplement 35 · standardAP
2019-08-22Labeling · Supplement 32 · standardAP
2018-12-31Labeling · Supplement 30 · standardAP
2015-10-20Labeling · Supplement 21 · standardAP
2014-11-05Labeling · Supplement 18 · standardAP
2014-11-05Labeling · Supplement 20 · standardAP
2013-09-30Manufacturing (CMC) · Supplement 10AP
2013-01-27Labeling · Supplement 17 · standardAP
2012-09-28Labeling · Supplement 15 · standardAP
2012-09-27Manufacturing (CMC) · Supplement 16AP
2012-01-11Labeling · Supplement 14AP
2012-01-11Labeling · Supplement 13AP
2011-11-04Labeling · Supplement 12AP
2011-02-22Labeling · Supplement 9AP
2010-09-20Labeling · Supplement 7AP
2008-11-25Labeling · Supplement 1AP
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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