Drug Approval Package: Abilify MyCite (aripiprazole)

Company: Otsuka Pharmaceutical Company, Ltd.
Application Number: 207202
Approval Date: 11/13/2017

Drugs@FDA information available about Abilify MyCite

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Other Action Letters (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: August 8, 2018

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