aripiprazole lauroxil

FDA Drug Profile — ARISTADA, ARISTADA INITIO

Drug Details

Generic Name
aripiprazole lauroxil
Brand Names
ARISTADA, ARISTADA INITIO
Application Number
NDA207533
Sponsor
Alkermes, Inc.
NDC Codes
10
Dosage Forms
INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
INTRAMUSCULAR
Active Ingredients
ARIPIPRAZOLE LAUROXIL

Indications and Usage

1 INDICATIONS AND USAGE ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).