APPLICATION
ANDA204994
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-05
LATEST ACTION
2026-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LACOSAMIDEPrescription
LACOSAMIDE 200MG · TABLET · ORAL
LACOSAMIDEPrescription
LACOSAMIDE 100MG · TABLET · ORAL
LACOSAMIDEPrescription
LACOSAMIDE 150MG · TABLET · ORAL
LACOSAMIDEPrescription
LACOSAMIDE 50MG · TABLET · ORAL
Approval history
2026-05-22Labeling · Supplement 9 · standardAP
2024-11-15Labeling · Supplement 6 · standardAP
2024-11-15Labeling · Supplement 4 · standardAP
2024-11-15Labeling · Supplement 5 · standardAP
2024-11-15Labeling · Supplement 3 · standardAP
2023-01-05UNKNOWN · 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.
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