lurasidone 80 mg
1 INDICATIONS AND USAGE Lurasidone hydrochloride tablets are indicated for: 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: 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 )
amneal pharmaceuticals llc
OVAL GREEN A80
A80 OVAL GREEN
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Amneal Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING
LURASIDONE HYDROCHLORIDE tablets, 20 mg are supplied as white to off-white, round shaped, biconvex coated tablet debossed with “A20” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-879-03 Bottles of 90: NDC 65162-879-09 Bottles of 500: NDC 65162-879-50
LURASIDONE HYDROCHLORIDE tablets, 40 mg are supplied as white to off-white, round shaped, biconvex coated tablet debossed with “A40” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-880-03 Bottles of 90: NDC 65162-880-09 Bottles of 500: NDC 65162-880-50
LURASIDONE HYDROCHLORIDE tablets, 60 mg are supplied as white to off-white, oblong shaped, biconvex coated tablet debossed with “A60” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-082-03 Bottles of 90: NDC 65162-082-09 Bottles of 500: NDC 65162-082-50
LURASIDONE HYDROCHLORIDE tablets, 80 mg are supplied as green to light green colored, oval shaped, biconvex coated tablet debossed with “A80” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-881-03 Bottles of 90: NDC 65162-881-09 Bottles of 500: NDC 65162-881-50
LURASIDONE HYDROCHLORIDE tablets, 120 mg are supplied as white to off-white, oval shaped, biconvex coated tablet debossed with “A120” on one side and plain on other side. They are available as follows: Bottles of 30: NDC 65162-882-03 Bottles of 90: NDC 65162-882-09 Bottles of 500: NDC 65162-882-50 Storage Store
LURASIDONE HYDROCHLORIDE tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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