Drug Approval Package

Trelstar Depot (Triptorelin Pamoate) Injection
Company:  Debio Recherche Pharmaceutique S.A.
Application No.:  20-715
Approval Date: 6/15/2000

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

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  

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

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

Date created: July 31, 2002

Back to Top    Drugs@FDA

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