APPLICATION
ANDA200475
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-19
LATEST ACTION
2024-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 1GM · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-08-27Labeling · Supplement 12 · standardAP
2023-11-16Labeling · Supplement 11 · standardAP
2021-01-29Labeling · Supplement 8 · standardAP
2021-01-29Labeling · Supplement 6 · standardAP
2021-01-29Labeling · Supplement 9 · standardAP
2021-01-29Labeling · Supplement 7 · standardAP
2014-03-18Labeling · Supplement 4 · standardAP
2011-12-19Not Applicable · OriginalAP
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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