← FDA DRUG APPROVALS

FDA NDA · NDA216185

MOTPOLY XR

lacosamide

Sponsor: AUCTA

APPLICATION
NDA216185
TYPE
NDA
ORIGINAL APPROVAL
2023-05-04
LATEST ACTION
2024-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MOTPOLY XR · ReferencePrescription
LACOSAMIDE 150MG · CAPSULE, EXTENDED RELEASE · ORAL
MOTPOLY XR · ReferencePrescription
LACOSAMIDE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
MOTPOLY XR · ReferencePrescription
LACOSAMIDE 100MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-06-07Efficacy · Supplement 1 · standard — Label ↗AP
2023-05-04Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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