Drug Approval Package

Climara (estradiol transdermal system)
Company:  Berlex Laboratories, Inc.
Application No.:  20-375/S-009
Approval Date: 3/23/1998

• Approval Letter(s) (PDF) (695 KB)

• Final Printed Labeling (PDF) (3 MB)

• Chemistry Review(s) & Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (1.1 MB)

• Administrative Document(s)/Correspondence (PDF) (2.7 MB)

Date created: September 10, 2001

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