APPLICATION
ANDA091338
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-29
LATEST ACTION
2021-06-08
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
2021-06-08Labeling · Supplement 16 · standardAP
2020-09-18Labeling · Supplement 12 · standardAP
2020-09-18Labeling · Supplement 15 · standardAP
2020-09-18Labeling · Supplement 13 · standardAP
2015-08-13Labeling · Supplement 7 · standardAP
2015-08-13Labeling · Supplement 8 · standardAP
2014-11-04Labeling · Supplement 5 · standardAP
2014-11-04Labeling · Supplement 6 · 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.
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.