APPLICATION
ANDA091557
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2024-08-27
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
2024-08-27Labeling · Supplement 12 · standardAP
2024-08-27Labeling · Supplement 13 · standardAP
2021-06-10Labeling · Supplement 11 · standardAP
2021-06-10Labeling · Supplement 10 · standardAP
2021-06-10Labeling · Supplement 9 · standardAP
2016-04-07Labeling · Supplement 8 · standardAP
2016-04-07Labeling · Supplement 7 · standardAP
2011-09-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.