← FDA DRUG APPROVALS

FDA NDA · NDA021284

METHYLPHENIDATE

Sponsor: SANDOZ

APPLICATION
NDA021284
TYPE
NDA
ORIGINAL APPROVAL
2002-06-05
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued

Products

RITALIN LA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
RITALIN LA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
RITALIN LA · ReferenceDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
RITALIN LA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
RITALIN LA · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 50 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 46 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 42 · standard — Letter ↗AP
2021-06-26Labeling · Supplement 43 · 901 required — Letter ↗AP
2019-11-19Labeling · Supplement 41 · standard — Letter ↗AP
2019-01-10Labeling · Supplement 29 · standard — Label ↗AP
2019-01-10Labeling · Supplement 16 · standard — Label ↗AP
2017-01-04Labeling · Supplement 34 · 901 required — Label ↗AP
2016-02-09Manufacturing (CMC) · Supplement 31 · standardAP
2015-06-02Manufacturing (CMC) · Supplement 26 · standardAP
2015-04-17Labeling · Supplement 27 · 901 required — Letter ↗AP
2014-10-27Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP
2013-12-13Labeling · Supplement 23 · standard — Letter ↗AP
2013-10-25Manufacturing (CMC) · Supplement 21 · standardAP
2013-06-07Labeling · Supplement 19 · standard — Label ↗AP
2013-05-06Labeling · Supplement 20 · standard — Letter ↗AP
2010-12-09Labeling · Supplement 18 · standard — Letter ↗AP
2010-11-15Labeling · Supplement 17 · unknown — Label ↗AP
2010-04-27Labeling · Supplement 10 · standard — Letter ↗AP
2007-04-25Labeling · Supplement 11 · standard — Label ↗AP
2006-08-08Labeling · Supplement 8 · standard — Letter ↗AP
2006-08-08Labeling · Supplement 6 · standard — Letter ↗AP
2004-04-08Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 1 · standardAP
2002-06-05Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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