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FDA NDA · NDA021802

FOCALIN XR

dexmethylphenidate hydrochloride

Sponsor: SANDOZ

APPLICATION
NDA021802
TYPE
NDA
ORIGINAL APPROVAL
2005-05-26
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG · CAPSULE, EXTENDED RELEASE · ORAL
FOCALIN XR · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 45 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 41 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 38 · standard — Letter ↗AP
2021-06-26Labeling · Supplement 39 · 901 required — Letter ↗AP
2019-11-19Labeling · Supplement 36 · standard — Label ↗AP
2019-01-10Labeling · Supplement 29 · standard — Label ↗AP
2019-01-10Labeling · Supplement 19 · standard — Label ↗AP
2017-01-04Labeling · Supplement 33 · 901 required — Label ↗AP
2015-12-04Manufacturing (CMC) · Supplement 31 · standardAP
2015-06-12Manufacturing (CMC) · Supplement 27 · standardAP
2015-04-17Labeling · Supplement 28 · 901 required — Letter ↗AP
2013-12-12Labeling · Supplement 26 · standard — Label ↗AP
2013-06-11Labeling · Supplement 25 · standard — Label ↗AP
2012-05-02Labeling · Supplement 24 · standard — Letter ↗AP
2011-04-21Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2010-11-15Labeling · Supplement 21 · standard — Letter ↗AP
2010-05-04Labeling · Supplement 17 · unknown — Label ↗AP
2009-10-23Labeling · Supplement 16 · standard — Letter ↗AP
2009-10-23Efficacy · Supplement 14 · standard — Letter ↗AP
2008-10-17Efficacy · Supplement 12 · unknown — Letter ↗AP
2007-04-25Labeling · Supplement 9 · standard — Label ↗AP
2006-08-01Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2006-08-01Labeling · Supplement 3 · standard — Letter ↗AP
2006-04-11Labeling · Supplement 5 · standard — Label ↗AP
2006-04-11Efficacy · Supplement 1 · unknown — Letter ↗AP
2005-05-26Type 3 - New Dosage Form · Original · standard — Pediatric Medical 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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