Drug Approval Package

 Seasonale (Levonorgestrel/Ethinyl Estradiol) Tablets
Company:  Barr Laboratories
Application No.:  021544
Approval Date: 9/5/2003

• 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)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

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

• Correspondence (PDF)  

Date created: March 242004

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