Drug Approval Package

 Mirena (Levonorgestrel-Releasing Intrauterine System)
Company:  Berlex Laboratories, Inc.
Application No.:  021225
Approval Date: 12/06/2000

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  

Date created: July 19, 2004

Back to Top    Drugs@FDA

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