← FDA DRUG APPROVALS

FDA NDA · NDA021278

FOCALIN

dexmethylphenidate hydrochloride

Sponsor: SANDOZ

APPLICATION
NDA021278
TYPE
NDA
ORIGINAL APPROVAL
2001-11-13
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FOCALIN · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
FOCALIN · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
FOCALIN · ReferencePrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET · ORAL

Approval history

2023-10-13Labeling · Supplement 31 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 28 · standard — Letter ↗AP
2021-06-26Labeling · Supplement 29 · 901 required — Letter ↗AP
2019-11-19Labeling · Supplement 26 · standard — Label ↗AP
2019-01-10Labeling · Supplement 19 · standard — Label ↗AP
2019-01-10Labeling · Supplement 11 · standard — Label ↗AP
2017-01-04Labeling · Supplement 23 · 901 required — Label ↗AP
2016-05-13Manufacturing (CMC) · Supplement 21 · standardAP
2015-12-04Manufacturing (CMC) · Supplement 20 · standardAP
2015-04-17Labeling · Supplement 18 · 901 required — Letter ↗AP
2013-12-12Labeling · Supplement 17 · standard — Letter ↗AP
2013-06-11Labeling · Supplement 16 · standard — Label ↗AP
2012-05-02Labeling · Supplement 15 · standard — Label ↗AP
2010-12-09Labeling · Supplement 13 · standard — Label ↗AP
2010-11-15Labeling · Supplement 12 · standard — Label ↗AP
2007-04-25Labeling · Supplement 8 · standard — Label ↗AP
2007-03-08Labeling · Supplement 7 · standard — Letter ↗AP
2006-08-24Labeling · Supplement 4 · standard — Label ↗AP
2006-08-24Labeling · Supplement 5 · standard — Letter ↗AP
2002-01-03Labeling · Supplement 1 · standardAP
2001-11-13Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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