APPLICATION
ANDA214672
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-19
LATEST ACTION
2023-03-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
LACOSAMIDEPrescription
LACOSAMIDE 10MG/ML · SOLUTION · ORAL
Approval history
2023-03-28Labeling · Supplement 1 · 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.