Drug Approval Package
Aloxi (Palonosetron
Hydrochloride) Injection
Company: Helsinn Healthcare S.A.
Application No.: 021372
Approval Date: 7/25/2003
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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)
Part 5 (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) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Correspondence (PDF)
Date created 1/15/2004
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