lurasidone hydrochloride 60 mg
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 tablets are 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 )
aurobindo pharma limited
OVAL WHITE L 10
L 10 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
LURASIDONE HYDROCHLORIDE Tablets 20 mg are white to off-white, round shaped, biconvex, film-coated tablets debossed with “L” on one side and “25” on other side. Bottles of 30 NDC 65862-953-30 Bottles of 90 NDC 65862-953-90 Bottles of 500 NDC 65862-953-05
LURASIDONE HYDROCHLORIDE Tablets 40 mg are white to off-white, round shaped, biconvex, film-coated tablets debossed with “L” on one side and “26” on other side. Bottles of 30 NDC 65862-954-30 Bottles of 90 NDC 65862-954-90 Bottles of 500 NDC 65862-954-05
LURASIDONE HYDROCHLORIDE Tablets 60 mg are white to off-white, oblong shaped, biconvex, film-coated tablets debossed with “L” on one side and “10” on other side. Bottles of 30 NDC 65862-955-30 Bottles of 90 NDC 65862-955-90 Bottles of 500 NDC 65862-955-05
LURASIDONE HYDROCHLORIDE Tablets 80 mg are pale green to green color, oval shaped, biconvex, film-coated tablets debossed with “L” on one side and “27” on other side. Bottles of 30 NDC 65862-956-30 Bottles of 90 NDC 65862-956-90 Bottles of 500 NDC 65862-956-05
LURASIDONE HYDROCHLORIDE Tablets 120 mg are white to off-white, oval shaped, biconvex, film-coated tablets debossed with “L” on one side and “29” on other side. Bottles of 30 NDC 65862-957-30 Bottles of 90 NDC 65862-957-90 Bottles of 500 NDC 65862-957-05 Storage Store
LURASIDONE HYDROCHLORIDE tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] .
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