Drug Approval Package
-
DepoDur (Morphine Sulfate
Extended-Release Liposome Injection)
Company: Skye Pharma Inc.
Application No.: 021671
Approval Date: 5/18/2004
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)
Date created: January 312006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-