APPLICATION
ANDA208831
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-21
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 40MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 10MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL
Approval history
2024-12-19Labeling · Supplement 13 · standardAP
2024-12-19Labeling · Supplement 14 · standardAP
2021-09-15Labeling · Supplement 6 · standardAP
2020-01-29Labeling · Supplement 4 · standardAP
2019-09-26Labeling · Supplement 2 · standardAP
2019-03-22Labeling · Supplement 1 · standardAP
2017-11-21UNKNOWN · 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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