Drug Approval Package
Relistor (Methylnaltrexone Bromide) Subcutaneous Injection
Company: Progenics Pharmaceuticals, Inc.
Application No.: 021964
Approval Date: 04/24/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
-
Printed Labeling (PDF)
-
Summary Review (PDF)
-
Officer/Employee List (PDF)
-
Office Director Memo (PDF)
- Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
-
Microbiology Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Risk Assessment and Risk Mitigation Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Approval Letter(s) (PDF)
Date created: June 3, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.