APPLICATION
ANDA090981
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-13
LATEST ACTION
2025-03-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-03-17Labeling · Supplement 16 · standardAP
2023-11-27Labeling · Supplement 14 · standardAP
2023-05-26Labeling · Supplement 6 · standardAP
2023-05-26Labeling · Supplement 12 · standardAP
2023-05-26Labeling · Supplement 4 · standardAP
2023-05-26Labeling · Supplement 9 · standardAP
2023-05-26Labeling · Supplement 3 · standardAP
2023-05-26Labeling · Supplement 8 · standardAP
2014-09-25Labeling · Supplement 2 · standardAP
2011-10-13OriginalAP
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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