← FDA DRUG APPROVALS

FDA NDA · NDA205489

COTEMPLA XR-ODT

methylphenidate

Sponsor: NEOS THERAPS INC

APPLICATION
NDA205489
TYPE
NDA
ORIGINAL APPROVAL
2017-06-19
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued

Products

COTEMPLA XR-ODT · ReferencePrescription
METHYLPHENIDATE 25.9MG · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
COTEMPLA XR-ODT · ReferencePrescription
METHYLPHENIDATE 8.6MG · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
COTEMPLA XR-ODT · ReferenceDiscontinued
METHYLPHENIDATE 34.6MG · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL
COTEMPLA XR-ODT · ReferencePrescription
METHYLPHENIDATE 17.3MG · TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 21 · standard — Letter ↗AP
2024-03-12Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2023-10-13Labeling · Supplement 12 · standard — Label ↗AP
2021-06-25Labeling · Supplement 7 · 901 required — Letter ↗AP
2017-06-19Type 3 - New Dosage Form · Original · standard — Label ↗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 →