Drug Approval Package

Yaz (drospirenone/ethinyl estradiol) for Oral Contraception and Premenstrual Dysphoric Disorder
Company: Berlex, Inc.
NDA: 021873
Approval Date: 10/4/2006

• Approval Letter(s) (PDF)
• Approvable Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)  
  • Part 2 (PDF)  
  • Part 3 (PDF)  
  • Part 4 (PDF)  
  • Part 5 (PDF) 
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)  
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) and Correspondence (PDF)

Date created: October 3, 2008

Updated: September 22, 2011

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