APPLICATION
ANDA078526
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
Approval history
2024-12-19Labeling · Supplement 16 · standardAP
2024-12-19Labeling · Supplement 14 · standardAP
2024-12-19Labeling · Supplement 12 · standardAP
2024-12-19Labeling · Supplement 17 · standardAP
2024-12-19Labeling · Supplement 15 · standardAP
2024-12-19Labeling · Supplement 13 · standardAP
2024-12-19Labeling · Supplement 11 · standardAP
2014-12-09Labeling · Supplement 9 · standardAP
2014-12-09Labeling · Supplement 7AP
2014-12-09Labeling · Supplement 10 · standardAP
2012-01-12REMS · Supplement 6AP
2011-09-27Labeling · Supplement 5AP
2010-10-27Labeling · Supplement 3AP
2010-10-27Labeling · Supplement 4AP
2009-08-20Labeling · Supplement 1AP
2009-01-15OriginalAP
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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