Drug Approval Package
-
Somatuline Depot
Company: Beafour Ipsen
Application No.: 022074
Approval Date: 08/30/2007
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Clinical Pharmacology and Biopharmaceutics Reivew (PDF)
- Pharmacology Review(s) (PDF)
-
Microbiology Review(s) (PDF)
-
Statistical Review (PDF)
Date created: November 6, 2007
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-