aripiprazole 10 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1) ] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2) ] Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3) ] Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole is an atypical antipsychotic. The oral formulation is 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 )
Dr. Reddy's Laboratories Inc
ROUND PINK SG 330
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
ARIPIPRAZOLE ORALLY DISINTEGRATING tablets, USP are round tablets with markings on either side.
ARIPIPRAZOLE ORALLY DISINTEGRATING tablets, USP are available in the strengths and packages listed in Table 28. Table 28:
ARIPIPRAZOLE ORALLY DISINTEGRATING Tablets Presentations Tablet Strength Tablet Color Tablet Markings Pack Size NDC Code 10 mg pink (with scattered specks) “SG 330” Bottle of 30 43598-733-30 15 mg pink (with scattered specks) “SG 331” Bottle of 30 43598-734-30 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].
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