APPLICATION
ANDA091261
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2024-10-09
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
2024-10-09Labeling · Supplement 18 · standardAP
2024-10-09Labeling · Supplement 19 · standardAP
2024-04-23Labeling · Supplement 15 · standardAP
2020-09-10Labeling · Supplement 11 · standardAP
2020-09-10Labeling · Supplement 14 · standardAP
2020-09-10Labeling · Supplement 9 · standardAP
2020-09-10Labeling · Supplement 7 · standardAP
2020-09-10Labeling · Supplement 10 · standardAP
2020-09-10Labeling · Supplement 5 · standardAP
2014-09-26Labeling · Supplement 4 · standardAP
2014-09-26Labeling · Supplement 3 · standardAP
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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