APPLICATION
ANDA078858
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2025-02-05
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
2025-02-05Labeling · Supplement 37 · standardAP
2024-01-24Labeling · Supplement 33 · standardAP
2024-01-24Labeling · Supplement 36 · standardAP
2020-02-05Labeling · Supplement 32 · standardAP
2020-02-05Labeling · Supplement 24 · standardAP
2020-02-05Labeling · Supplement 27 · standardAP
2020-02-05Labeling · Supplement 31 · standardAP
2020-02-05Labeling · Supplement 26 · standardAP
2016-01-14Labeling · Supplement 20AP
2016-01-14Labeling · Supplement 21 · standardAP
2014-09-18Labeling · Supplement 18 · standardAP
2014-09-18Labeling · Supplement 16 · standardAP
2014-09-18Labeling · Supplement 19 · standardAP
2014-09-18Labeling · Supplement 13AP
2011-12-29Labeling · Supplement 10AP
2010-06-23Labeling · Supplement 8AP
2010-03-31REMS · Supplement 7AP
2009-11-13Labeling · Supplement 6AP
2009-11-13Labeling · Supplement 5AP
2009-11-05Labeling · Supplement 4AP
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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