APPLICATION
ANDA078103
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-11
LATEST ACTION
2024-01-31
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
2024-01-31Labeling · Supplement 54 · standardAP
2022-08-29Labeling · Supplement 46 · standardAP
2022-08-29Labeling · Supplement 50 · standardAP
2022-08-29Labeling · Supplement 49 · standardAP
2020-05-28Labeling · Supplement 44 · standardAP
2019-08-08Labeling · Supplement 39 · standardAP
2019-08-08Labeling · Supplement 43 · standardAP
2015-10-08Labeling · Supplement 33 · standardAP
2014-11-05Labeling · Supplement 31 · standardAP
2012-11-20Labeling · Supplement 27 · standardAP
2012-01-09Labeling · Supplement 24AP
2010-10-27Labeling · Supplement 18AP
2009-04-14Labeling · Supplement 3AP
2008-11-18Labeling · Supplement 8AP
2008-04-25Labeling · Supplement 5AP
2007-05-11OriginalAP
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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