latuda lurasidone hydrochloride tablet film coated
1 INDICATIONS AND USAGE LATUDA is 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 )] . LATUDA 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 )
sunovion pharmaceuticals inc.
ROUND WHITE L 20
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16 HOW SUPPLIED/STORAGE AND HANDLING LATUDA tablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L20” (20 mg), “L40” (40 mg), “L80” (80 mg) or “L120” (120 mg). Tablets are supplied in the following strengths and package configurations ( Table 39 ). Table 39: Package Configuration for LATUDA Tablets Tablet Strength Package Configuration NDC Code 20 mg Bottles of 30 63402-302-30 Bottles of 90 63402-302-90 Bottles of 500 63402-302-50 Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-302-10 Carton 63402-302-01 Blister 40 mg Bottles of 30 63402-304-30 Bottles of 90 63402-304-90 Bottles of 500 63402-304-50 Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-304-10 Carton 63402-304-01 Blister 60 mg Bottles of 30 63402-306-30 Bottles of 90 63402-306-90 Bottles of 500 63402-306-50 Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-306-10 Carton 63402-306-01 Blister 80 mg Bottles of 30 63402-308-30 Bottles of 90 63402-308-90 Bottles of 500 63402-308-50 Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-308-10 Carton 63402-308-01 Blister 120 mg Bottles of 30 63402-312-30 Bottles of 90 63402-312-90 Bottles of 500 63402-312-50 Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-312-10 Carton 63402-312-01 Blister Storage Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature] .
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