Drug Approval Package

Lovenox (Enoxaparin Sodium) Injection
Company:  Rhone-Poulenc Rorer Pharmaceutical Inc.
Application No.:  0202164/S015
Approval Date: 12/31/1998

• Approval Letter(s) & Approvable Letter(s) (PDF) (2.8 MB)

• Final Printed Labeling (PDF) (3 MB)

• Medical Review(s)

  Part 1 (PDF) (2.7 MB)	Part 4 (PDF) (2.8 MB)	Part 7 (PDF) (2.5 MB)
  Part 2 (PDF) (3 MB)	Part 5 (PDF) (2.9 MB)	Part 8 (PDF) (2.9 MB)
  Part 3 (PDF) (3 MB)	Part 6 (PDF) (2.8 MB)

• Chemistry Review(s) (PDF) (438 KB)

• Environmental Assessment
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (2.1 MB)
  Part 3 (PDF) (2.3 MB)

• Statistical Review(s)
  Part 1 (PDF) (2.6 MB)
  Part 2 (PDF) (2.7 MB)
  Part 3 (PDF) (2 MB)

• Microbiology Review(s) (PDF) (389 KB)

• Clinical Pharmacology Biopharmaceutics Review(s)

  Part 1 (PDF) (2.7 MB)	Part 5 (PDF) (3 MB)	Part 9 (PDF) (2.9 MB)
  Part 2 (PDF) (2.9 MB)	Part 6 (PDF) (2.5 MB)	Part 10 (PDF) (1.7 MB)
  Part 3 (PDF) (3 MB)	Part 7 (PDF) (2.8 MB)
  Part 4 (PDF) (3 MB)	Part 8 (PDF) (2.8 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.9 MB)
  Part 2 (PDF) (2.6 MB)
  Part 3 (PDF) (2.9 MB)
  Part 4 (PDF) (2.8 MB)
  Part 5 (PDF) (2.6 MB)

Date created: September 10, 2001

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