Drug Approval Package

Taxol (Paclitaxel) Injection
Company:  Bristol-Myers
Application No.:  20-262/S-026, 027, 028
Approval Date: 4/09/1998

• Approval Letter (PDF) (360 KB)

• 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)

• Statistical Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.7 MB)

• Administrative Document(s)/Correspondence (PDF) (2.1 MB)

Date created: July 1, 2005

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.