APPLICATION
ANDA209234
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-21
LATEST ACTION
2024-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EZETIMIBEPrescription
EZETIMIBE 10MG · TABLET · ORAL
Approval history
2024-08-15Labeling · Supplement 14 · standardAP
2024-06-17Labeling · Supplement 13 · standardAP
2022-12-16Labeling · Supplement 12 · standardAP
2018-05-21Manufacturing (CMC) · Supplement 1AP
2017-12-21UNKNOWN · 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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