APPLICATION
ANDA204312
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-01
LATEST ACTION
2025-02-21
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-02-21Labeling · Supplement 13 · standardAP
2023-05-22Labeling · Supplement 9 · standardAP
2020-04-20Labeling · Supplement 2 · standardAP
2020-04-20Labeling · Supplement 8 · standardAP
2020-04-20Labeling · Supplement 6 · standardAP
2020-04-20Labeling · Supplement 4 · standardAP
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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