← FDA DRUG APPROVALS

FDA NDA · NDA201367

BANZEL

rufinamide

Sponsor: EISAI INC

APPLICATION
NDA201367
TYPE
NDA
ORIGINAL APPROVAL
2011-03-03
LATEST ACTION
2023-05-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

BANZEL · ReferencePrescription
RUFINAMIDE 40MG/ML · SUSPENSION · ORAL

Approval history

2023-05-30Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2019-11-28Labeling · Supplement 8 · standard — Letter ↗AP
2015-10-06Manufacturing (CMC) · Supplement 6 · standardAP
2015-06-25Labeling · Supplement 5 · standard — Letter ↗AP
2015-02-12Efficacy · Supplement 3 · priority — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 2 · standardAP
2011-06-10REMS · Supplement 1 — Letter ↗AP
2011-03-03Type 3 - New Dosage Form · Original · standard — Summary Review ↗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 →