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Aripiprazole oral

FDA Drug Profile — Aripiprazole

Drug Details

Generic Name
Aripiprazole oral
Brand Names
Aripiprazole
Application Number
ANDA216150
Sponsor
NorthStar RxLLC
NDC Codes
3
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
ARIPIPRAZOLE

Indications and Usage

1 INDICATIONS AND USAGE Aripiprazole oral solution is 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) ] • Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] • Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole oral solution is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)