Drug Approval Package

Angeliq (Drospirenone/17B-Estradiol) Tablets
Company: Berlex, Inc.
Application No.:  021355
Approval Date: 09/28/2005

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence
  Part 1 (PDF)  
  Part 2 (PDF) 

Date created:  September 11, 2007

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