Drug Approval Package

Flolan (Epoprostenol Sodium) Injection
Company:  Glaxo Wellcome, Inc.
Application No.:  20-444/S003
Approval Date: 4/14/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

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

• Statistical Review(s)(PDF)  

• Administrative Document(s)(PDF)  

• Correspondence(PDF)  

Date created: November 20, 2001

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