Drug Approval Package
Camptosar (Irinotecan Hydrochloride) Injection
Company: Pharmacia & Upjohn
Application No.: 20-571/S-008
Approval Date: 10/22/1998
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Approval Letter (PDF) (335 K MB)
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Medical Review(s)
Part 1 (PDF) (1.9 MB)
Part 1 (PDF) (2.4 MB)
Part 1 (PDF) (1.8 MB) -
Chemistry Review(s) & Pharmacology Review(s) (PDF) (277 KB)
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Statistical Review(s) (PDF) (1.7 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Document(s)/Correspondence (PDF) (2.1 MB)
Date created: March 30, 2001; last updated: July 1, 2005
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