APPLICATION
ANDA211663
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-10
LATEST ACTION
2024-12-10
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
2024-12-10UNKNOWN · 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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