Lotronex (Alosetron HCL)
Company:  Glaxo Wellcome Inc.
Application No.:  021107
Approval Date: 2/11/00

• Approval Letter(s) (936 KB)

• Final Printed Labeling
  Part 1 (2.5 MB)
  Part 2 (2.1 MB)

• Medical Review(s)

  Part 1 (3 MB)	Part 6 (3 MB)	Part 11 (3 MB)
  Part 2 (3 MB)	Part 7 (2.8 MB)	Part 12 (2.9 MB)
  Part 3 (3 MB)	Part 8 (3 MB)	Part 13 (2.9 MB)
  Part 4 (3 MB)	Part 9 (2.9 MB)	Part 14 (2.7 MB)
  Part 5 (3 MB)	Part 10 (3 MB)	Part 15 (2.8 MB)

• Chemistry Review(s) (1.3 MB)

• Pharmacology Review(s)

  Part 1 (2.8 MB)	Part 8 (3 MB)	Part 15 (2.9 MB)
  Part 2 (3 MB)	Part 9 (3 MB)	Part 16 (2.9 MB)
  Part 3 (3 MB)	Part 10 (2.9 MB)	Part 17 (2.8 MB)
  Part 4 (3 MB)	Part 11 (2.9 MB)	Part 18 (3 MB)
  Part 5 (2.8 MB)	Part 12 (2.9 MB)	Part 19 (2.3 MB)
  Part 6 (2.8 MB)	Part 13 (3 MB)	Part 20 (2.5 MB)
  Part 7 (3 MB)	Part 14 (3 MB)

• Statistical Review(s)
  Part 1 (2.8 MB)
  Part 2 (2.7 MB)
  Part 3 (2.9 MB)
  Part 4 (2.9 MB)
  Part 5 (2.9 MB)
  Part 6 (2.1 MB)
  Part 7 (2.1 MB)

• Clinical Pharmacology Biopharmaceutics Review(s)
  Part 1 (2.9 MB)
  Part 2 (3 MB)
  Part 3 (3 MB)
  Part 4 (2.9 MB)
  Part 5 (2.9 MB)
  Part 6 (3 MB)
  Part 7 (3 MB)

• Administrative Document(s)/Correspondence
  Part 1 (2.4 MB)
  Part 2 (2.1 MB)

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Date created: June 18, 2001

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