Drug Approval Package

Abilify Discmelt (Aripiprazole) Orally Disintegrating Tablets
Company: Otsuka Pharmaceutical Co., Ltd.
Application No.:  021729
Approval Date: 06/07/2006

• Approval Letter(s) (PDF)  

• Approvable Letter (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created:  August 22, 2007

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