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FDA NDA · NDA021475

METHYLIN

Sponsor: SPECGX LLC

APPLICATION
NDA021475
TYPE
NDA
ORIGINAL APPROVAL
2003-04-15
LATEST ACTION
2025-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

METHYLIN · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
METHYLIN · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
METHYLIN · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2025-01-08Labeling · Supplement 13 · standard — Label ↗AP
2023-10-13Labeling · Supplement 12 · standard — Letter ↗AP
2021-06-25Labeling · Supplement 11 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 10 · 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 — Label ↗AP
2013-06-14Labeling · Supplement 6 · standard — Letter ↗AP
2010-10-18Labeling · Supplement 5 · unknown — Letter ↗AP
2007-06-07Labeling · Supplement 4 · standard — Letter ↗AP
2006-08-10Labeling · Supplement 2 · standard — Letter ↗AP
2003-04-15Type 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.

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