← FDA DRUG APPROVALS

FDA NDA · NDA010187

RITALIN

methylphenidate hydrochloride

Sponsor: SANDOZ

APPLICATION
NDA010187
TYPE
NDA
ORIGINAL APPROVAL
1955-12-05
LATEST ACTION
2025-02-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RITALIN · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
RITALIN · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET · ORAL
RITALIN · ReferencePrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2025-02-04Labeling · Supplement 94 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 96 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 92 · standard — Letter ↗AP
2021-06-26Labeling · Supplement 93 · 901 required — Letter ↗AP
2019-11-19Labeling · Supplement 91 · standard — Letter ↗AP
2019-01-10Labeling · Supplement 71 · standard — Label ↗AP
2019-01-10Labeling · Supplement 82 · standard — Label ↗AP
2017-01-04Labeling · Supplement 87 · 901 required — Label ↗AP
2016-05-27Manufacturing (CMC) · Supplement 84 · standardAP
2015-10-02Manufacturing (CMC) · Supplement 81 · standardAP
2015-04-17Labeling · Supplement 80 · 901 required — Letter ↗AP
2014-07-14Manufacturing (CMC) · Supplement 78 · standardAP
2014-02-07Manufacturing (CMC) · Supplement 76 · standardAP
2013-12-13Labeling · Supplement 77 · standard — Label ↗AP
2013-10-25Manufacturing (CMC) · Supplement 75 · standardAP
2013-06-07Labeling · Supplement 74 · standard — Letter ↗AP
2010-12-09Labeling · Supplement 73 · standard — Letter ↗AP
2010-11-15Labeling · Supplement 72 · unknown — Label ↗AP
2007-04-25Labeling · Supplement 69 · standard — Letter ↗AP
2006-08-08Labeling · Supplement 66 · standard — Label ↗AP
2006-08-08Labeling · Supplement 67 · standard — Label ↗AP
2004-05-21Labeling · Supplement 57 · standard — Letter ↗AP
2004-05-21Labeling · Supplement 58 · standard — Letter ↗AP
2002-06-12Manufacturing (CMC) · Supplement 62 · standardAP
2002-05-29Manufacturing (CMC) · Supplement 61 · standardAP
2002-01-11Labeling · Supplement 60 · standard — Letter ↗AP
2001-08-15Manufacturing (CMC) · Supplement 59 · standardAP
2000-01-11Manufacturing (CMC) · Supplement 56 · standardAP
1999-04-13Manufacturing (CMC) · Supplement 55 · standardAP
1998-11-24Manufacturing (CMC) · Supplement 54 · standardAP
1998-09-17Manufacturing (CMC) · Supplement 53 · standardAP
1998-08-12Manufacturing (CMC) · Supplement 52 · standardAP
1998-04-24Manufacturing (CMC) · Supplement 51 · standardAP
1998-02-20Labeling · Supplement 50 · standardAP
1997-07-09Labeling · Supplement 39AP
1997-07-09Labeling · Supplement 48 · standardAP
1997-07-09Labeling · Supplement 46 · standardAP
1997-07-09Labeling · Supplement 42AP
1995-12-15Labeling · Supplement 47 · standardAP
1995-06-01Manufacturing (CMC) · Supplement 45 · standardAP
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 →