APPLICATION
ANDA203468
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-21
LATEST ACTION
2024-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-08-29Labeling · Supplement 10 · standardAP
2021-11-17Manufacturing (CMC) · Supplement 7 · unknownAP
2021-11-16Labeling · Supplement 6 · standardAP
2021-11-16Labeling · Supplement 5 · standardAP
2021-11-16Labeling · Supplement 3 · standardAP
2021-11-16Labeling · Supplement 1 · standardAP
2021-11-16Labeling · Supplement 8 · standardAP
2015-05-21UNKNOWN · 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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