APPLICATION
ANDA202095
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-06
LATEST ACTION
2021-11-10
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
2021-11-10Labeling · Supplement 8 · standardAP
2021-11-10Labeling · Supplement 7 · standardAP
2021-11-10Labeling · Supplement 5 · standardAP
2021-11-10Labeling · Supplement 3 · standardAP
2016-12-15Labeling · Supplement 2 · standardAP
2016-12-15Labeling · Supplement 1 · standardAP
2016-06-06Not Applicable · OriginalAP
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.