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Last Updated: April 22, 2021

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Details for New Drug Application (NDA): 202683

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NDA 202683 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, and Torrent, and is included in twenty-eight NDAs. It is available from forty-one suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 202683
Tradename:ARIPIPRAZOLE
Applicant:Orchid Hlthcare
Ingredient:aripiprazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202683

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 23, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 23, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 23, 2017TE:ABRLD:No

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