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
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-