abilify aripiprazole tablet abilify aripiprazole solution abilify aripiprazole tablet orally disintegrating abilify aripiprazole injection solution
1 INDICATIONS AND USAGE ABILIFY (aripiprazole) Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution 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 Injection is indicated for the treatment of: Agitation associated with Schizophrenia or bipolar mania ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's disorder ( 14.5 ) The injection is indicated for: Agitation associated with Schizophrenia or bipolar mania ( 14.6 )
otsuka america pharmaceutical, inc.
RECTANGLE GREEN A 006 2
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ABILIFY ® (
ARIPIPRAZOLE) Tablets have markings on one side an are available in the strengths and packages listed in Table 32. Table 32: 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 ABILIFY DISCMELT ® (
ARIPIPRAZOLE) Orally Disintegrating Tablets are round tablets with markings on either side. ABILIFY DISCMELT is available in the strengths and packages listed in Table 33. Table 33: ABILIFY DISCMELT Orally Disintegrating Tablet Presentations Tablet Strength Tablet Color Tablet Markings Pack Size NDC Code 10 mg pink (with scattered specks) "A" and "640" "10" Blister of 30 59148-640-23 15 mg yellow (with scattered specks) "A" and "641" "15" Blister of 30 59148-641-23 ABILIFY ® (
ARIPIPRAZOLE) Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. ABILIFY Oral Solution is available as follows: 150 mL bottle NDC 59148-013-15 ABILIFY ® (
ARIPIPRAZOLE) Injection for intramuscular use is available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials as follows: 9.75 mg/1.3 mL single-dose vial NDC 59148-016-65 16.2 Storage Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Oral Solution Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date. Injection Store at 25ºC (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Protect from light by storing in the original container. Retain in carton until time of use.
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