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1 INDICATIONS AND USAGE ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )

otsuka america pharmaceutical, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] off label use` `[4] pain` `[5] nausea` `[6] diarrhoea` `[7] alopecia` `[8] headache` `[9] dyspnoea` `[10] arthralgia`

6 years ago

RECTANGLE GREEN A 006 2

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ABILIFY ® (

ARIPIPRAZOLE) Tablets have markings on one side and are available in the strengths and packages listed in Table 28. Table 28: ABILIFY Tablet Presentations Tablet Strength Tablet Color/Shape Tablet Markings Pack Size NDC Code 2 mg green modified rectangle "A-006" and "2" Bottle of 30 59148-006-13 5 mg blue modified rectangle "A-007" and "5" Bottle of 30 Blister of 100 59148-007-13 59148-007-35 10 mg pink modified rectangle "A-008" and "10" Bottle of 30 Blister of 100 59148-008-13 59148-008-35 15 mg yellow round "A-009" and "15" Bottle of 30 Blister of 100 59148-009-13 59148-009-35 20 mg white round "A-010" and "20" Bottle of 30 Blister of 100 59148-010-13 59148-010-35 30 mg pink round "A-011" and "30" Bottle of 30 Blister of 100 59148-011-13 59148-011-35 Storage Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].

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