← FDA DRUG APPROVALS

FDA NDA · NDA021419

METHYLIN

methylphenidate hydrochloride

Sponsor: SPECGX LLC

APPLICATION
NDA021419
TYPE
NDA
ORIGINAL APPROVAL
2002-12-19
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

METHYLIN · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
METHYLIN · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL

Approval history

2023-10-13Labeling · Supplement 23 · standard — Letter ↗AP
2021-07-19Labeling · Supplement 10 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 20 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 14 · 901 required — Label ↗AP
2015-04-17Labeling · Supplement 9 · 901 required — Label ↗AP
2014-09-15Manufacturing (CMC) · Supplement 8 · standardAP
2013-12-12Labeling · Supplement 7 · standard — Letter ↗AP
2013-06-14Labeling · Supplement 6 · standard — Letter ↗AP
2010-10-18Labeling · Supplement 4 · unknown — Letter ↗AP
2007-06-07Labeling · Supplement 1 · standard — Letter ↗AP
2006-08-10Labeling · Supplement 3 · standard — Letter ↗AP
2002-12-19Type 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 →