Application Nr Approved Date Route Status External Links
ANDA206174 2016-09-12 Oral RX 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: Schizophrenia [see Clinical Studies (14.1)] 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 Formulations Are Indicated For: Schizophrenia (14.1)

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Starch, Corn STARCH, CORN Unresolved

Active Ingredients ( 1 Total)

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

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