Drug Approval Package

Aloxi (Palonosetron Hydrochloride) Intravenous Injection
Company:  August Consulting
Application No.:  021372s008s010
Approval Date: 2/29/2008

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: December 11, 2009

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