APPLICATION
ANDA208619
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-31
LATEST ACTION
2023-01-31
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 1GM/100ML (10MG/ML) · INJECTABLE · INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 1.5GM/100ML (15MG/ML) · INJECTABLE · INTRAVENOUS
LEVETIRACETAM IN SODIUM CHLORIDEPrescription
LEVETIRACETAM 500MG/100ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2023-01-31UNKNOWN · Original · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.