Drug Approval Package

Epoprostenol for injection, 1.5 mg vial
Company: GeneraMedix, Inc.
NDA: 022260
Approval Date: 6/27/2008

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s)(PDF)
• Printed Labeling(PDF) [note for vision impaired users]
  
• Summary Review(PDF)
• Officer/Employee List  (PDF)
• Medical Review(s)(PDF)  
• Chemistry Review(s)(PDF)
• Environmental Assessment(PDF)
• Microbiology Review(s)(PDF)
• Other Review(s)(PDF)
• Administrative Document(s) and Correspondence(PDF)

Date created: November 6, 2008

Back to Top    Drugs@FDA

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