← FDA DRUG APPROVALS

FDA NDA · NDA021259

METHYLPHENIDATE HYDROCHLORIDE CD

methylphenidate hydrochloride

Sponsor: LANNETT

APPLICATION
NDA021259
TYPE
NDA
ORIGINAL APPROVAL
2001-04-03
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
METADATE CD · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 36 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 34 · standard — Letter ↗AP
2022-04-22Labeling · Supplement 25 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 32 · 901 required — Letter ↗AP
2017-01-04Labeling · Supplement 30 · 901 required — Label ↗AP
2015-06-15Manufacturing (CMC) · Supplement 28 · standardAP
2015-04-17Labeling · Supplement 29 · 901 required — Letter ↗AP
2013-12-13Labeling · Supplement 27 · standard — Label ↗AP
2013-06-04Labeling · Supplement 26 · standard — Letter ↗AP
2013-05-06Labeling · Supplement 24 · standard — Letter ↗AP
2013-05-06Labeling · Supplement 23 · standard — Label ↗AP
2010-10-18Labeling · Supplement 22 · unknown — Label ↗AP
2009-04-16Labeling · Supplement 21 · standard — Label ↗AP
2008-08-26Labeling · Supplement 19 · standard — Letter ↗AP
2007-05-04Labeling · Supplement 20 · standard — Label ↗AP
2006-08-10Labeling · Supplement 18 · standard — Label ↗AP
2006-02-19Manufacturing (CMC) · Supplement 17 — Letter ↗AP
2003-09-22Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
2003-06-19Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2003-05-27Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2002-11-06Manufacturing (CMC) · Supplement 4 · standardAP
2002-11-06Manufacturing (CMC) · Supplement 3 · standardAP
2002-09-18Manufacturing (CMC) · Supplement 2 · standardAP
2002-04-09Labeling · Supplement 1 · standard — Letter ↗AP
2001-04-03Type 3 - New Dosage Form · Original · standard — 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 →