APPLICATION
ANDA078101
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2014-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET · ORAL
Approval history
2014-09-18Labeling · Supplement 8 · standardAP
2014-09-18Labeling · Supplement 11 · standardAP
2014-09-18Labeling · Supplement 10 · standardAP
2012-08-22Labeling · Supplement 7 · standardAP
2010-10-27Labeling · Supplement 6AP
2010-10-27Labeling · Supplement 4AP
2010-10-27Labeling · Supplement 5AP
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.