APPLICATION
ANDA090484
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-05
LATEST ACTION
2024-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
Approval history
2024-12-19Labeling · Supplement 13 · standardAP
2024-12-19Labeling · Supplement 11 · standardAP
2024-12-19Labeling · Supplement 8 · standardAP
2024-12-19Labeling · Supplement 12 · standardAP
2024-12-19Labeling · Supplement 10 · standardAP
2024-12-19Labeling · Supplement 9 · standardAP
2024-12-19Labeling · Supplement 7 · standardAP
2014-12-09Labeling · Supplement 5 · standardAP
2014-12-09Labeling · Supplement 3AP
2014-12-09Labeling · Supplement 6 · standardAP
2012-01-12REMS · Supplement 2AP
2010-11-17Labeling · Supplement 1AP
2010-08-05OriginalAP
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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