APPLICATION
ANDA206557
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-13
LATEST ACTION
2023-10-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SIMVASTATINPrescription
SIMVASTATIN 20MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 5MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 40MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 10MG · TABLET · ORAL
SIMVASTATINPrescription
SIMVASTATIN 80MG · TABLET · ORAL
Approval history
2023-10-27Labeling · Supplement 5 · standardAP
2023-10-27Labeling · Supplement 6 · standardAP
2023-10-27Labeling · Supplement 7 · standardAP
2020-05-14Labeling · Supplement 4 · standardAP
2019-07-30Labeling · Supplement 3 · standardAP
2019-07-30Labeling · Supplement 1 · standardAP
2017-11-13UNKNOWN · Original · standardAP
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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