vraylar cariprazine capsule gelatin coated vraylar cariprazine kit
1 INDICATIONS AND USAGE VRAYLAR ® is indicated for: 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 )] Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults [see Clinical Studies ( 14.3 )] Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.4 )] VRAYLAR is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults ( 1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults ( 1 ) Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults ( 1 ) Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 )
allergan, inc.
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vraylar cariprazine 4.5 mg capsule
allergan, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VRAYLAR (
CARIPRAZINE) capsules are supplied as follows: capsule Strength Imprint Codes capsule Color Package Configuration NDC Code 1.5 mg FL 1.5 white cap and body Blister pack of 7 61874-115-17 Bottle of 30 61874-115-30 Bottle of 90 61874-115-90 Box of 20 (Hospital Unit Dose) 61874-115-20 3 mg FL 3 green to blue-green cap and white body Bottle of 30 61874-130-30 Bottle of 90 61874-130-90 Box of 20 (Hospital Unit Dose) 61874-130-20 4.5 mg FL 4.5 green to blue-green cap and body Bottle of 30 61874-145-30 Bottle of 90 61874-145-90 6 mg FL 6 purple cap and white body Bottle of 30 61874-160-30 Bottle of 90 61874-160-90 (1) 1.5 mg, (6) 3 mg FL 1.5, FL 3 Mixed Blister pack of 7 61874-170-08 16.2 Storage and Handling Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.
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