APPLICATION
ANDA091627
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-26
LATEST ACTION
2021-07-13
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2021-07-13Labeling · Supplement 9 · standardAP
2021-07-13Labeling · Supplement 13 · standardAP
2021-07-13Labeling · Supplement 11 · standardAP
2021-07-13Labeling · Supplement 8 · standardAP
2016-11-30Labeling · Supplement 4 · standardAP
2016-11-30Labeling · Supplement 2 · standardAP
2016-11-30Labeling · Supplement 7 · standardAP
2016-11-30Labeling · Supplement 5 · standardAP
2013-06-26Not 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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