APPLICATION
ANDA078042
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2013-02-28
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
2013-02-28Labeling · Supplement 9 · standardAP
2011-11-17REMS · Supplement 8AP
2010-11-23Labeling · Supplement 6AP
2010-11-22Labeling · Supplement 7AP
2010-04-22Labeling · Supplement 5AP
2010-02-26Labeling · Supplement 4AP
2010-02-26Labeling · Supplement 2AP
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.
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