APPLICATION
ANDA090893
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-17
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2024-11-22Labeling · Supplement 23 · standardAP
2023-10-24Labeling · Supplement 22 · standardAP
2023-03-16Labeling · Supplement 13 · standardAP
2023-03-16Labeling · Supplement 18 · standardAP
2023-03-16Labeling · Supplement 14 · standardAP
2023-03-16Labeling · Supplement 20 · standardAP
2023-03-16Labeling · Supplement 15 · standardAP
2015-12-24Labeling · Supplement 9 · standardAP
2015-12-24Labeling · Supplement 10 · standardAP
2014-11-03Labeling · Supplement 1 · standardAP
2014-11-03Labeling · Supplement 6 · standardAP
2013-04-12Labeling · Supplement 3AP
2011-10-17OriginalAP
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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