Maintena (aripiprazole) for extended-release injectable suspension

Company:  Otsuka Pharmaceutical Company, Ltd.
Application No.:  202971s003
Approval Date: 12/05/2014

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• Approval Letter(s) (PDF)
• Printed Labeling (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Statistical Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

 

Date created: July 24, 2015

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