Drug Approval Package
Esclim (Estradiol Transdermal System)
Company: Fournier Research, Inc.
Application No.: 20847
Approval Date: 8/4/1998
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Approval Letter (PDF) (197 KB)
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Medical Review(s) (PDF) (1.4 MB)
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Chemistry Review(s), Pharmacology Review(s), Statistical Review(s), and Microbiology Reviews (PDF) (1.7 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2 MB)
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Administrative Documents(s) and Correspondence (PDF) (1.4 MB)
Date created: March 08, 2001; last update: July 5, 2005
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