← FDA DRUG APPROVALS

FDA NDA · NDA021121

CONCERTA

methylphenidate hydrochloride

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021121
TYPE
NDA
ORIGINAL APPROVAL
2000-08-01
LATEST ACTION
2026-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CONCERTA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL
CONCERTA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL
CONCERTA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
CONCERTA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 18MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-04-10Labeling · Supplement 54 · standard — Letter ↗AP
2026-02-02Labeling · Supplement 34 · standard — Label ↗AP
2026-02-02Labeling · Supplement 40 · standard — Label ↗AP
2026-02-02Labeling · Supplement 45 · standard — Label ↗AP
2025-09-23Labeling · Supplement 53 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 49 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 44 · 901 required — Letter ↗AP
2017-01-04Labeling · Supplement 38 · 901 required — Label ↗AP
2016-11-30Manufacturing (CMC) · Supplement 37 · standard — Review ↗AP
2015-04-17Labeling · Supplement 35 · standard — Label ↗AP
2014-08-11Manufacturing (CMC) · Supplement 33 · standardAP
2013-12-12Labeling · Supplement 32 · standard — Label ↗AP
2013-07-30Manufacturing (CMC) · Supplement 30 · standardAP
2013-06-12Labeling · Supplement 31 · standard — Label ↗AP
2013-05-03Labeling · Supplement 29 · standard — Label ↗AP
2010-11-23Labeling · Supplement 26 · unknown — Label ↗AP
2010-11-23Labeling · Supplement 27 · unknown — Letter ↗AP
2009-11-04Efficacy · Supplement 22 · standard — Letter ↗AP
2009-01-14Manufacturing (CMC) · Supplement 20AP
2008-06-27Efficacy · Supplement 17 · unknown — Label ↗AP
2008-06-27Labeling · Supplement 15 · standard — Letter ↗AP
2007-05-03Labeling · Supplement 14 · standard — Label ↗AP
2006-09-07Labeling · Supplement 12 · standard — Letter ↗AP
2006-09-07Labeling · Supplement 9 · standard — Label ↗AP
2004-10-21Efficacy · Supplement 8 · priority — Pediatric Medical Review ↗AP
2002-12-18Manufacturing (CMC) · Supplement 5 · standardAP
2002-04-01Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2002-03-04Manufacturing (CMC) · Supplement 3 · standardAP
2001-04-26Labeling · Supplement 2 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 1 · standardAP
2000-08-01Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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