APPLICATION
ANDA202968
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-26
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 40MG · TABLET · ORAL
EZETIMIBE AND SIMVASTATINDiscontinued
EZETIMIBE 10MG, SIMVASTATIN 10MG · TABLET · ORAL
Approval history
2025-01-29Labeling · Supplement 10 · standardAP
2021-10-01Labeling · Supplement 5 · standardAP
2020-01-24Labeling · Supplement 4 · standardAP
2019-09-16Labeling · Supplement 2 · standardAP
2019-09-16Labeling · Supplement 3 · standardAP
2017-04-26UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.