APPLICATION
ANDA091399
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-14Labeling · Supplement 29 · standardAP
2023-10-19Labeling · Supplement 28 · standardAP
2023-06-16Labeling · Supplement 25 · standardAP
2019-11-25Labeling · Supplement 18 · standardAP
2019-11-25Labeling · Supplement 16 · standardAP
2019-11-25Labeling · Supplement 14 · standardAP
2019-11-25Labeling · Supplement 17 · standardAP
2019-11-25Manufacturing (CMC) · Supplement 21AP
2016-01-14Labeling · Supplement 12 · standardAP
2016-01-14Labeling · Supplement 10 · standardAP
2016-01-14Labeling · Supplement 11 · standardAP
2014-02-18Labeling · Supplement 6 · standardAP
2014-02-18Labeling · Supplement 2 · standardAP
2013-04-03Labeling · Supplement 4AP
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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