MILSAPERIDONE

FDA Drug Profile — BYSANTI

MILSAPERIDONE is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand name including BYSANTI. Available dosage forms: tablet, kit.

Drug Details

Generic Name
MILSAPERIDONE
Brand Names
BYSANTI
Application Number
NDA220358
Sponsor
Vanda Pharmaceuticals Inc.
NDC Codes
16
Dosage Forms
TABLET, KIT
Routes
ORAL
Active Ingredients
MILSAPERIDONE

Indications and Usage

1 INDICATIONS AND USAGE BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ] . BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )