aripiprazole

FDA Drug Profile — ABILIFY MAINTENA, aripiprazole, ARIPIPRAZOLE

Drug Details

Generic Name
aripiprazole
Brand Names
ABILIFY MAINTENA, aripiprazole, ARIPIPRAZOLE
Application Number
NDA202971
Sponsor
OTSUKA PHARMACEUTICAL CO., LTD.
NDC Codes
44
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE, KIT, TABLET, SOLUTION
Routes
ORAL
Active Ingredients
ARIPIPRAZOLE

Indications and Usage

1 INDICATIONS AND USAGE Aripiprazole Oral Tablets are indicated for the treatment of: Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia. ( 14.1 ) Irritability Associated with Autistic Disorder. ( 14.4 ) Treatment of Tourette’s disorder. ( 14.5 )