APPLICATION
ANDA078560
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-26
LATEST ACTION
2024-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EZETIMIBEPrescription
EZETIMIBE 10MG · TABLET · ORAL
Approval history
2024-06-03Labeling · Supplement 11 · standardAP
2024-02-16Labeling · Supplement 8 · 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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