APPLICATION
ANDA209781
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-20
LATEST ACTION
2025-08-06
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-08-06Labeling · Supplement 5 · standardAP
2023-09-26Labeling · Supplement 2 · 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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