APPLICATION
ANDA209222
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-22
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 80MG · TABLET · ORAL
Approval history
2024-07-15Labeling · Supplement 14 · standardAP
2022-12-16Labeling · Supplement 12 · standardAP
2021-02-23Labeling · Supplement 8 · standardAP
2020-01-29Labeling · Supplement 6 · standardAP
2019-09-26Labeling · Supplement 5 · standardAP
2019-04-16Labeling · Supplement 2 · standardAP
2017-12-22UNKNOWN · 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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