APPLICATION
ANDA200909
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-26
LATEST ACTION
2021-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 40MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 10MG · TABLET · ORAL
Approval history
2021-03-17Labeling · Supplement 4 · standardAP
2020-01-29Labeling · Supplement 2 · standardAP
2017-04-26Not Applicable · OriginalAP
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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