aripiprazole lauroxil

FDA Drug Profile — ARISTADA INITIO, ARISTADA

aripiprazole lauroxil is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including ARISTADA INITIO, ARISTADA. Available dosage form: injection, suspension, extended release.

Drug Details

Generic Name
aripiprazole lauroxil
Brand Names
ARISTADA INITIO, ARISTADA
Application Number
NDA209830
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 INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA ® when used for the treatment of schizophrenia in adults ( 1 ).