← FDA DRUG APPROVALS

FDA NDA · NDA200603

LATUDA

lurasidone hydrochloride

Sponsor: SUNOVION PHARMS INC

APPLICATION

NDA200603

TYPE

NDA

ORIGINAL APPROVAL

2010-10-28

LATEST ACTION

2025-01-22

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

LATUDA · ReferencePrescription

LURASIDONE HYDROCHLORIDE 120MG · TABLET · ORAL

LATUDA · ReferencePrescription

LURASIDONE HYDROCHLORIDE 80MG · TABLET · ORAL

LATUDA · ReferencePrescription

LURASIDONE HYDROCHLORIDE 60MG · TABLET · ORAL

LATUDA · ReferencePrescription

LURASIDONE HYDROCHLORIDE 20MG · TABLET · ORAL

LATUDA · ReferencePrescription

LURASIDONE HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 41 · standard — Label ↗AP

2019-12-04Labeling · Supplement 35 · standard — Letter ↗AP

2018-03-05Efficacy · Supplement 29 · standard — Label ↗AP

2017-09-25Labeling · Supplement 30 · standard — Label ↗AP

2017-02-23Labeling · Supplement 28 · 901 required — Label ↗AP

2017-01-27Efficacy · Supplement 26 · priority — Letter ↗AP

2017-01-27Efficacy · Supplement 27 · priority — Letter ↗AP

2017-01-11Labeling · Supplement 21 · standard — Label ↗AP

2016-12-20Manufacturing (CMC) · Supplement 25 · standardAP

2016-07-08Manufacturing (CMC) · Supplement 24 · standardAP

2016-03-29Manufacturing (CMC) · Supplement 23 · standardAP

2015-07-30Manufacturing (CMC) · Supplement 20 · standardAP

2015-01-05Manufacturing (CMC) · Supplement 18 · standardAP

2014-05-21Manufacturing (CMC) · Supplement 14 · standardAP

2014-02-28Manufacturing (CMC) · Supplement 17 · standardAP

2013-09-03Labeling · Supplement 16 · standard — Label ↗AP

2013-07-12Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP

2013-06-28Efficacy · Supplement 11 · standard — Label ↗AP

2013-06-28Efficacy · Supplement 10 · standard — Label ↗AP

2013-06-13Manufacturing (CMC) · Supplement 12 · standardAP

2013-01-22Labeling · Supplement 13 · standard — Label ↗AP

2013-01-22Labeling · Supplement 9 · standard — Label ↗AP

2012-04-26Labeling · Supplement 7 · standard — Label ↗AP

2012-04-26Efficacy · Supplement 5 · standard — Label ↗AP

2011-12-07Labeling · Supplement 6 · standard — Label ↗AP

2011-12-07Labeling · Supplement 4 · standard — Label ↗AP

2010-12-10Labeling · Supplement 1 · standard — Label ↗AP

2010-10-28Type 1 - New Molecular Entity · 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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