aripiprazole 10 MG Oral Tablet
1 INDICATIONS AND USAGE Aripiprazole Oral Tablets are indicated for the treatment of: 1. Schizophrenia [see CLINICAL STUDIES (14.1) ] 2. Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.'s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole tablets are an atypical antipsychotic. The oral formulation is indicated for: 1. Schizophrenia (14.1) 2. Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2)
aphena pharma solutions - tennessee, llc
RECTANGLE PINK 10 A
10 A RECTANGLE PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Aripiprazole tablets 2 mg are available for oral administration as green, rectangular, slightly biconvex tablets, engraved "2" on one side and "A" on the other side. Bottles of 30 (NDC 60429-446-30) Aripiprazole tablets 5 mg are available for oral administration as blue, rectangular, slightly biconvex tablets, engraved “5” on one side and “A” on the other side. Bottles of 30 (NDC 60429-447-30) Aripiprazole tablets 10 mg are available for oral administration as pink, rectangular, slightly biconvex tablets, engraved “10” on one side and “A” on the other side. Bottles of 30 (NDC 60429-448-30) Aripiprazole tablets 15 mg are available for oral administration as yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side and “APO” on the other side. Bottles of 30 (NDC 60429-449-30) Aripiprazole tablets 20 mg are available for oral administration as white to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side and “APO” on the other side. Bottles of 30 (NDC 60429-450-30) Aripiprazole tablets 30 mg are available for oral administration as pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side and “APO” on the other side. Bottles of 30 (NDC 60429-451-30) 16.2 Storage Tablets Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].
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