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Medicines · US (FDA)
Antipsychotics

FDA 2023

Other antipsychotics

Brexpiprazole

Approved 18 Mar 2023OralTablet

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BREXPIPRAZOLE 1MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BREXPIPRAZOLE 4MG · TabletANDA213512-006 · Discontinued
BREXPIPRAZOLE 2MG · TabletANDA213512-004 · Discontinued
BREXPIPRAZOLE 0.5MG · TabletANDA213512-002 · Discontinued
BREXPIPRAZOLE 3MG · TabletANDA213512-005 · Discontinued
BREXPIPRAZOLE 1MG · TabletThis page
BREXPIPRAZOLE 0.25MG · TabletANDA213512-001 · Discontinued
BREXPIPRAZOLE 4MG · TabletANDA213782-006 · Discontinued
BREXPIPRAZOLE 2MG · TabletANDA213782-004 · Discontinued
BREXPIPRAZOLE 0.5MG · TabletANDA213782-002 · Discontinued
BREXPIPRAZOLE 3MG · TabletANDA213782-005 · Discontinued
BREXPIPRAZOLE 1MG · TabletANDA213782-003 · Discontinued
BREXPIPRAZOLE 0.25MG · TabletANDA213782-001 · Discontinued

More in antipsychotics

Paliperidone PalmitateInjectable

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

BREXPIPRAZOLE 0.25MG · TabletANDA213788-001 · Tentative approval

BREXPIPRAZOLE 1MG · TabletANDA213683-003 · Prescription

BREXPIPRAZOLE 0.25MG · TabletANDA213683-001 · Prescription

BREXPIPRAZOLE 4MG · TabletANDA213683-006 · Prescription

BREXPIPRAZOLE 2MG · TabletANDA213683-004 · Prescription

BREXPIPRAZOLE 0.5MG · TabletANDA213683-002 · Prescription

BREXPIPRAZOLE 3MG · TabletANDA213683-005 · Prescription

BREXPIPRAZOLE 4MG · TabletANDA213587-006 · Tentative approval

BREXPIPRAZOLE 2MG · TabletANDA213587-004 · Tentative approval

BREXPIPRAZOLE 0.5MG · TabletANDA213587-002 · Tentative approval

BREXPIPRAZOLE 3MG · TabletANDA213587-005 · Tentative approval

BREXPIPRAZOLE 1MG · TabletANDA213587-003 · Tentative approval

BREXPIPRAZOLE 0.25MG · TabletANDA213587-001 · Tentative approval

BREXPIPRAZOLE 3MG · TabletANDA213659-005 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213659-003 · Discontinued

BREXPIPRAZOLE 0.25MG · TabletANDA213659-001 · Discontinued

BREXPIPRAZOLE 4MG · TabletANDA213659-006 · Discontinued

BREXPIPRAZOLE 2MG · TabletANDA213659-004 · Discontinued

BREXPIPRAZOLE 0.5MG · TabletANDA213659-002 · Discontinued

BREXPIPRAZOLE 3MG · TabletANDA213570-005 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213570-003 · Discontinued

BREXPIPRAZOLE 0.25MG · TabletANDA213570-001 · Discontinued

BREXPIPRAZOLE 4MG · TabletANDA213570-006 · Discontinued

BREXPIPRAZOLE 2MG · TabletANDA213570-004 · Discontinued

BREXPIPRAZOLE 0.5MG · TabletANDA213570-002 · Discontinued

BREXPIPRAZOLE 3MG · TabletANDA213758-005 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213758-003 · Discontinued

BREXPIPRAZOLE 0.25MG · TabletANDA213758-001 · Discontinued

BREXPIPRAZOLE 4MG · TabletANDA213758-006 · Discontinued

BREXPIPRAZOLE 2MG · TabletANDA213758-004 · Discontinued

BREXPIPRAZOLE 0.5MG · TabletANDA213758-002 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213477-003 · Tentative approval

BREXPIPRAZOLE 0.25MG · TabletANDA213477-001 · Tentative approval

BREXPIPRAZOLE 4MG · TabletANDA213477-006 · Tentative approval

BREXPIPRAZOLE 2MG · TabletANDA213477-004 · Tentative approval

BREXPIPRAZOLE 0.5MG · TabletANDA213477-002 · Tentative approval

BREXPIPRAZOLE 3MG · TabletANDA213477-005 · Tentative approval

BREXPIPRAZOLE 4MG · TabletANDA213660-006 · Discontinued

BREXPIPRAZOLE 2MG · TabletANDA213660-004 · Discontinued

BREXPIPRAZOLE 0.5MG · TabletANDA213660-002 · Discontinued

BREXPIPRAZOLE 3MG · TabletANDA213660-005 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213660-003 · Discontinued

BREXPIPRAZOLE 0.25MG · TabletANDA213660-001 · Discontinued

BREXPIPRAZOLE 3MG · TabletANDA213692-005 · Discontinued

BREXPIPRAZOLE 1MG · TabletANDA213692-003 · Discontinued

BREXPIPRAZOLE 0.25MG · TabletANDA213692-001 · Discontinued

BREXPIPRAZOLE 4MG · TabletANDA213692-006 · Discontinued

BREXPIPRAZOLE 2MG · TabletANDA213692-004 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA213512.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Brexpiprazole
Drug class: Other antipsychotics
Group: Antipsychotics
Route: Oral
Dosage form: Tablet
Applicant: Lupin
Status: Discontinued
FDA approval: 18 Mar 2023
Application: ANDA213512-003
RxCUI: 1658314

Guidelines

Guidelines in psychiatry293 guidelines in the library

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FDA 2021Lybalviolanzapine · Tablet

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FDA 2020Asenapine MaleateTablet

FDA 2019Caplytalumateperone tosylate · Capsule

FDA 2019Secuadoasenapine · System

FDA 2018Nuplazidpimavanserin tartrate · Capsule

FDA 2017Abilify Mycite Kitaripiprazole · Tablet

FDA 2016Quetiapine FumarateTablet, extended release

FDA 2015PimozideTablet

FDA 2015Vraylarcariprazine hydrochloride · Capsule

FDA 2015ClozapineTablet, orally disintegrating

FDA 2015AripiprazoleSolution