Drug Approval Package
Climara (Estradiol Transdermal System)
Company: Berlex Laboratories, Inc.
Application No.: 020-994 & 020-375/s011
Approval Date: 3/5/1999
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Approval Letter & Printed Labeling (PDF) (2.4 MB)
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Medical Review(s)
Part 1 (PDF) (2.5 MB)
Part 2 (PDF) (2.3 MB) -
Chemistry Review(s) (PDF) (165 KB)
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Statistical Review(s)
Part 1 (PDF) (1.7 MB)
Part 2 (PDF) (1.8 MB) -
Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (845 KB)
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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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