Drug Approval Package
Taxol (Paclitaxel) Injection
Company: Bristol-Myers
Application No.: 20-262/S-026, 027, 028
Approval Date: 4/09/1998
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Approval Letter (PDF) (360 KB)
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Medical Review(s)
Part 1 (PDF) (1.3 MB)
Part 2 (PDF) (1.9 MB)
Part 3 (PDF) (2.8 MB)
Part 4 (PDF) (2.5 MB)
Part 5 (PDF) (2.6 MB) -
Chemistry Review(s), Environmental Assessment & Pharmacology Review(s) (PDF) (1 MB)
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Statistical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.7 MB)
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Administrative Document(s)/Correspondence (PDF) (2.1 MB)
Date created: July 1, 2005
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