Application Nr Approved Date Route Status External Links
ANDA078583 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Aripiprazole ARIPIPRAZOLE ZINC1851149

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