← FDA DRUG APPROVALS

FDA NDA · NDA202810

OXTELLAR XR

oxcarbazepine

Sponsor: SUPERNUS PHARMS

APPLICATION
NDA202810
TYPE
NDA
ORIGINAL APPROVAL
2012-10-19
LATEST ACTION
2024-08-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

OXTELLAR XR · ReferencePrescription
OXCARBAZEPINE 600MG · TABLET, EXTENDED RELEASE · ORAL
OXTELLAR XR · ReferencePrescription
OXCARBAZEPINE 150MG · TABLET, EXTENDED RELEASE · ORAL
OXTELLAR XR · ReferencePrescription
OXCARBAZEPINE 300MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-08-14Labeling · Supplement 20 · standard — Label ↗AP
2023-08-08Labeling · Supplement 14 · standard — Letter ↗AP
2018-12-13Efficacy · Supplement 10 · standard — Letter ↗AP
2016-06-17Manufacturing (CMC) · Supplement 7 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 6 · standardAP
2015-12-04Labeling · Supplement 5 · standard — Label ↗AP
2015-09-11Manufacturing (CMC) · Supplement 4 · standardAP
2013-08-23Manufacturing (CMC) · Supplement 2 · standardAP
2013-06-14Manufacturing (CMC) · Supplement 1 · standardAP
2012-10-19Type 3 - New Dosage Form · Original · standard — Pediatric Medical 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 →