APPLICATION
ANDA203059
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-09
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-11-14Labeling · Supplement 29 · standardAP
2023-11-16Labeling · Supplement 27 · standardAP
2021-11-16Labeling · Supplement 22 · standardAP
2020-08-13Labeling · Supplement 20 · standardAP
2020-08-13Labeling · Supplement 12 · standardAP
2020-08-13Labeling · Supplement 13 · standardAP
2020-07-21Labeling · Supplement 10 · standardAP
2020-07-21Labeling · Supplement 11 · standardAP
2015-06-14Labeling · Supplement 7 · standardAP
2015-06-14Labeling · Supplement 8 · standardAP
2015-06-14Labeling · Supplement 4 · standardAP
2013-09-09UNKNOWN · 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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