APPLICATION
ANDA203931
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-12
LATEST ACTION
2024-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EZETIMIBEPrescription
EZETIMIBE 10MG · TABLET · ORAL
Approval history
2024-09-23Labeling · Supplement 5 · standardAP
2024-01-30Labeling · Supplement 3 · standardAP
2017-06-12UNKNOWN · 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.
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