Application Nr Approved Date Route Status External Links
ANDA204171 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aripiprazole Oral Solution Is 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 )] 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 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 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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