APPLICATION
ANDA091291
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2026-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-04-09Labeling · Supplement 8 · standardAP
2021-04-05Labeling · Supplement 6 · standardAP
2021-04-05Labeling · Supplement 7 · standardAP
2021-04-05Labeling · Supplement 5 · standardAP
2012-06-25Labeling · Supplement 2 · standardAP
2012-04-26Labeling · Supplement 1AP
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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