Aripiprazole orally disintegrating

FDA Drug Profile — Aripiprazole

Aripiprazole orally disintegrating is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Aripiprazole. Available dosage form: tablet.

Drug Details

Generic Name
Aripiprazole orally disintegrating
Brand Names
Aripiprazole
Application Number
ANDA207240
Sponsor
Dr. Reddy's Laboratories Inc
NDC Codes
6
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ARIPIPRAZOLE

Indications and Usage

1 INDICATIONS AND USAGE Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1) ] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [ see Clinical Studies (14.2) ] Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3) ] Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette’s disorder ( 14.5 )