APPLICATION
ANDA090992
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-27
LATEST ACTION
2024-09-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 100MG/ML · SOLUTION · ORAL
Approval history
2024-09-16Labeling · Supplement 11 · standardAP
2023-10-24Labeling · Supplement 10 · standardAP
2023-05-19Labeling · Supplement 5 · standardAP
2023-05-19Labeling · Supplement 8 · standardAP
2023-05-19Labeling · Supplement 6 · standardAP
2023-05-19Labeling · Supplement 9 · standardAP
2023-05-19Labeling · Supplement 7 · standardAP
2015-08-10Labeling · Supplement 3 · standardAP
2015-08-10Labeling · Supplement 1AP
2015-08-10Labeling · Supplement 4 · standardAP
2012-10-26Labeling · Supplement 2 · standardAP
2009-10-27OriginalAP
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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