APPLICATION
ANDA078918
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-29
LATEST ACTION
2021-01-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
Approval history
2021-01-11Labeling · Supplement 8 · standardAP
2021-01-11Labeling · Supplement 9 · standardAP
2021-01-11Labeling · Supplement 10 · standardAP
2016-02-10Labeling · Supplement 7AP
2011-11-29REMS · Supplement 6AP
2010-11-17Labeling · Supplement 4AP
2010-09-21Labeling · Supplement 3AP
2009-09-15Labeling · Supplement 2AP
2009-09-15Labeling · Supplement 1AP
2009-04-29OriginalAP
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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