aripiprazole

FDA Drug Profile — ARIPIPRAZOLE, aripiprazole, ABILIFY MAINTENA

aripiprazole is listed in the FDA National Drug Code directory with 46 NDC codes, marketed under brand names including ARIPIPRAZOLE, aripiprazole, ABILIFY MAINTENA. Available dosage forms: tablet, injection, powder, lyophilized, for suspension, extended release, kit, solution.

Drug Details

Generic Name
aripiprazole
Brand Names
ARIPIPRAZOLE, aripiprazole, ABILIFY MAINTENA
Application Number
ANDA205064
Sponsor
Camber Pharmaceuticals, Inc.
NDC Codes
46
Dosage Forms
TABLET, INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE, KIT, SOLUTION
Routes
ORAL
Active Ingredients
ARIPIPRAZOLE

Indications and Usage

1 INDICATIONS & USAGE Aripiprazole tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette’s Disorder ( 14.5 )