APPLICATION
ANDA076920
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-15
LATEST ACTION
2012-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
Approval history
2012-04-26Labeling · Supplement 4AP
2011-09-20REMS · Supplement 3AP
2010-09-21Labeling · Supplement 2AP
2009-07-31Labeling · Supplement 1AP
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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