APPLICATION
ANDA078154
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2025-02-14
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
2025-02-14Labeling · Supplement 44 · standardAP
2024-01-24Labeling · Supplement 28 · standardAP
2024-01-24Labeling · Supplement 34 · standardAP
2024-01-24Labeling · Supplement 30 · standardAP
2024-01-24Labeling · Supplement 39 · standardAP
2024-01-24Labeling · Supplement 37 · standardAP
2024-01-24Labeling · Supplement 29 · standardAP
2024-01-24Labeling · Supplement 43 · standardAP
2016-01-14Labeling · Supplement 21 · standardAP
2016-01-14Labeling · Supplement 22 · standardAP
2016-01-14Labeling · Supplement 20 · standardAP
2014-09-26Labeling · Supplement 19 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2012-07-20REMS · Supplement 11AP
2011-09-15Labeling · Supplement 10AP
2009-11-12REMS · Supplement 5AP
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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