lurasidone hydrochloride
lurasidone hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including lurasidone hydrochloride, Latuda. Available dosage forms: tablet, film coated, tablet, powder.
Drug Details
- Generic Name
- lurasidone hydrochloride
- Brand Names
- lurasidone hydrochloride, Latuda
- Application Number
- ANDA208037
- Sponsor
- MAJOR PHARMACEUTICALS
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- LURASIDONE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Lurasidone hydrochloride tablets are indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )] . Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of: Schizophrenia in adults and adolescents (13 to 17 years) ( 1 , 14.1 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate ( 1 , 14.2 )