APPLICATION
ANDA090383
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-16
LATEST ACTION
2023-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL
Approval history
2023-10-26Labeling · Supplement 16 · standardAP
2023-05-23Labeling · Supplement 15 · standardAP
2023-05-23Labeling · Supplement 13 · standardAP
2023-05-23Labeling · Supplement 14 · standardAP
2023-05-23Labeling · Supplement 12 · standardAP
2020-06-15Labeling · Supplement 11 · standardAP
2019-08-22Labeling · Supplement 10 · standardAP
2016-11-14Labeling · Supplement 7 · standardAP
2016-11-14Labeling · Supplement 8 · standardAP
2014-11-04Labeling · Supplement 3 · standardAP
2014-11-04Labeling · Supplement 2 · standardAP
2012-12-29Labeling · Supplement 1AP
2011-09-16OriginalAP
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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