Aripiprazole oral

FDA Drug Profile — Aripiprazole

Aripiprazole oral is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Aripiprazole. Available dosage form: solution.

Drug Details

Generic Name
Aripiprazole oral
Brand Names
Aripiprazole
Application Number
ANDA216150
Sponsor
ATLANTIC BIOLOGICALS CORP.
NDC Codes
4
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)