APPLICATION
ANDA078106
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-10
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
Approval history
2025-02-21Labeling · Supplement 19 · standardAP
2023-01-05Labeling · Supplement 16 · standardAP
2023-01-05Labeling · Supplement 14 · standardAP
2023-01-05Labeling · Supplement 17 · standardAP
2023-01-05Labeling · Supplement 15 · standardAP
2015-10-19Labeling · Supplement 12 · standardAP
2015-10-19Labeling · Supplement 11 · standardAP
2014-09-18Labeling · Supplement 10 · standardAP
2014-09-18Labeling · Supplement 6 · standardAP
2014-09-18Labeling · Supplement 9 · standardAP
2010-10-28Labeling · Supplement 2AP
2009-02-10OriginalAP
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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