APPLICATION
ANDA091668
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-01
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-22Labeling · Supplement 3 · standardAP
2023-11-27Labeling · Supplement 2 · standardAP
2021-06-11Labeling · Supplement 1 · standardAP
2012-11-01OriginalAP
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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