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FDA NDA · NDA205422

REXULTI

brexpiprazole

Sponsor: OTSUKA

APPLICATION
NDA205422
TYPE
NDA
ORIGINAL APPROVAL
2015-07-10
LATEST ACTION
2026-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

REXULTI · ReferencePrescription
BREXPIPRAZOLE 3MG · TABLET · ORAL
REXULTI · ReferencePrescription
BREXPIPRAZOLE 1MG · TABLET · ORAL
REXULTI · ReferencePrescription
BREXPIPRAZOLE 0.25MG · TABLET · ORAL
REXULTI · ReferencePrescription
BREXPIPRAZOLE 4MG · TABLET · ORAL
REXULTI · ReferencePrescription
BREXPIPRAZOLE 2MG · TABLET · ORAL
REXULTI · ReferencePrescription
BREXPIPRAZOLE 0.5MG · TABLET · ORAL

Approval history

2026-04-30Labeling · Supplement 17 · standard — Letter ↗AP
2025-05-09Efficacy · Supplement 14 · standard — Letter ↗AP
2024-12-11Labeling · Supplement 13 · standard — Letter ↗AP
2024-05-07Efficacy · Supplement 11 · priority — Letter ↗AP
2023-05-10Efficacy · Supplement 9 · priority — Label ↗AP
2022-10-06Labeling · Supplement 8 · standard — Letter ↗AP
2021-12-27Efficacy · Supplement 7 · priority — Letter ↗AP
2020-06-17Labeling · Supplement 5 · standard — Letter ↗AP
2018-02-09Labeling · Supplement 3 · standard — Label ↗AP
2017-02-23Labeling · Supplement 2 · 901 required — Label ↗AP
2016-09-23Efficacy · Supplement 1 · standard — Letter ↗AP
2015-07-10Efficacy · Original · standard — Label ↗AP
2015-07-10Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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