← FDA DRUG APPROVALS

FDA NDA · NDA212839

XCOPRI

cenobamate

Sponsor: SK LIFE

APPLICATION
NDA212839
TYPE
NDA
ORIGINAL APPROVAL
2019-11-21
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XCOPRI · ReferencePrescription
CENOBAMATE 200MG · TABLET · ORAL
XCOPRI · ReferencePrescription
CENOBAMATE 100MG · TABLET · ORAL
XCOPRI · ReferencePrescription
CENOBAMATE 25MG · TABLET · ORAL
XCOPRI · ReferencePrescription
CENOBAMATE 150MG · TABLET · ORAL
XCOPRI · ReferencePrescription
CENOBAMATE 50MG · TABLET · ORAL
XCOPRI · ReferencePrescription
CENOBAMATE 12.5MG · TABLET · ORAL

Approval history

2025-08-18Labeling · Supplement 13 · standard — Letter ↗AP
2024-04-05Labeling · Supplement 9 · standard — Letter ↗AP
2024-04-05Labeling · Supplement 10 · standard — Letter ↗AP
2024-01-26Labeling · Supplement 8 · standard — Label ↗AP
2022-06-27Labeling · Supplement 7 · standard — Letter ↗AP
2022-06-27Labeling · Supplement 6 · standard — Letter ↗AP
2020-08-31Labeling · Supplement 1 · standard — Letter ↗AP
2019-11-21Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →