APPLICATION
ANDA208803
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-12
LATEST ACTION
2024-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EZETIMIBEPrescription
EZETIMIBE 10MG · TABLET · ORAL
Approval history
2024-07-10Labeling · Supplement 14 · standardAP
2022-12-16Labeling · Supplement 9 · standardAP
2017-06-12UNKNOWN · 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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