Drug Approval Package

Climara (Estradiol Transdermal System)
Company:  Berlex Laboratories, Inc.
Application No.:  020-994 & 020-375/s011
Approval Date: 3/5/1999

• Approval Letter & Printed Labeling (PDF) (2.4 MB)

• Medical Review(s)
  Part 1 (PDF) (2.5 MB)
  Part 2 (PDF) (2.3 MB)

• Chemistry Review(s) (PDF) (165 KB)

• Statistical Review(s)
  Part 1 (PDF) (1.7 MB)
  Part 2 (PDF) (1.8 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (845 KB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (2.1 MB)
  Part 2 (PDF) (2.5 MB

 

Date created: March 30, 2001; last update: July 5, 2005

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