Drug Approval Package

Estradiol Transdermal System
Company:  Menorest Manufacturing, Inc.
Application No.:  20-538/S-006
Approval Date: 1/8/1999

• Approval Letter (PDF) (775 KB)

• Printed Labeling (PDF) (2.4 MB)

• Medical Review(s) & Chemistry Review(s) (PDF) (1.3 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) & Administrative Document(s) (PDF) (2.5 MB)

• Correspondence (PDF) (2.7 MB)

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

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