APPLICATION
ANDA090025
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2025-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
Approval history
2025-02-14Labeling · Supplement 45 · standardAP
2024-01-24Labeling · Supplement 30 · standardAP
2024-01-24Labeling · Supplement 39 · standardAP
2024-01-24Labeling · Supplement 29 · standardAP
2024-01-24Labeling · Supplement 41 · standardAP
2024-01-24Labeling · Supplement 44 · standardAP
2024-01-24Labeling · Supplement 28 · standardAP
2024-01-24Labeling · Supplement 34 · standardAP
2016-01-14Labeling · Supplement 22 · standardAP
2016-01-14Labeling · Supplement 20 · standardAP
2016-01-14Labeling · Supplement 21 · standardAP
2014-09-26Labeling · Supplement 19 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2012-07-19REMS · Supplement 11AP
2011-09-20Labeling · Supplement 9AP
2009-11-16Labeling · Supplement 6AP
2009-01-15OriginalAP
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.