Drug Approval Package

YAZ (drospirenone 3mg/ethinyl estradiol 0.02mg) Tablets
Company: Berlex, Inc.
Application No.:  022045
Approval Date: 01/26/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Environmental Assessment (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: February 22, 2008

Updated: October 3, 2011

Back to Top    Drugs@FDA

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