Drug Approval Package
Abilify (Aripiprazole) Tablets
Company: Otsuka Pharmaceutical Co., Ltd.
Application No.: 21-436
Approval Date: 11/15/2002
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Part 7 (PDF) -
Statistical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: March 07, 2003
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