Drug Approval Package

Fragmin (Dalteparin Sodium) Injection
Company:  Pharmacia and UpJohn
Application No.:  020287/S10
Approval Date: 5/25/1999

• Approval Letter(s) (PDF) (744 KB)

• Final Printed Labeling (PDF) (3 MB)

• Medical Review(s)

  Part 1 (PDF) (3 MB)	Part 4 (PDF) (3 MB)	Part 7 (PDF) (2.5 MB)
  Part 2 (PDF) (3 MB)	Part 5 (PDF) (3 MB)
  Part 3 (PDF) (3 MB)	Part 6 (PDF) (2.6 MB)

• Chemistry Review(s) (PDF) (332 KB)

• Statistical Review(s)
  Part 1 (PDF) (2.2 MB)
  Part 2 (PDF) (2.2 MB)
  Part 3 (PDF) (2.2 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (3 MB)
  Part 2 (PDF) (2.9 MB)
  Part 3 (PDF) (2.9 MB)

Date created: March 30, 2001

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