APPLICATION
ANDA208699
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-27
LATEST ACTION
2024-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
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
EZETIMIBE AND SIMVASTATINPrescription
EZETIMIBE 10MG, SIMVASTATIN 20MG · TABLET · ORAL
Approval history
2024-06-10Labeling · Supplement 4 · standardAP
2024-06-10Labeling · Supplement 5 · standardAP
2022-02-02Labeling · Supplement 2 · standardAP
2020-01-24Labeling · Supplement 1 · standardAP
2019-06-27UNKNOWN · 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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