APPLICATION
ANDA078993
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 35 · standardAP
2024-01-24Labeling · Supplement 19 · standardAP
2024-01-24Labeling · Supplement 33 · standardAP
2024-01-24Labeling · Supplement 17 · standardAP
2024-01-24Labeling · Supplement 15 · standardAP
2024-01-24Labeling · Supplement 28 · standardAP
2024-01-24Labeling · Supplement 24 · standardAP
2024-01-24Labeling · Supplement 14 · standardAP
2024-01-24Labeling · Supplement 20 · standardAP
2014-09-26Labeling · Supplement 9 · standardAP
2014-09-26Labeling · Supplement 8 · standardAP
2014-09-26Labeling · Supplement 10 · standardAP
2013-02-28Labeling · Supplement 6 · standardAP
2012-04-25Labeling · Supplement 5AP
2010-12-13Labeling · Supplement 2AP
2009-06-29Labeling · 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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