Drug Approval Package
Taxol (Paclitaxel) Injection
Company: Bristol-Myers Squibb
Application No.: NDA 20-262/S-024
Approval Date: 6/30/1998
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Approval Letter (PDF) (884 KB)
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Medical Review(s)
Part 1 (PDF) (2.6 MB) Part 4 (PDF) (2.9 MB) Part 7 (PDF) (2.4 MB) Part 2 (PDF) (2.6 MB) Part 5 (PDF) (3 MB) Part 8 (PDF) (3 MB) Part 3 (PDF) (2.8 MB) Part 6 (PDF) (2.8 MB) -
Chemistry Review(s) (PDF) (328 KB)
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Environmental Assessment & Pharmacology Review(s) (PDF) (2.2 MB)
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Statistical Review(s)
Part 1 (PDF) (2.6 MB)
Part 2 (PDF) (2.7 MB)
Part 3 (PDF) (2.l4 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.5 MB)
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Administrative Document(s) (PDF) (2.8 MB)
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Correspondence (PDF) (1.5 MB)
Date created: March 30, 2001; last update: July 5, 2005
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