Drug Approval Package
-
Naglazyme (Galsulfase) Injection
Company: Biomarin Pharmaceutical, Inc.
Application No.: 125117
Approval Date: 5/31/2005
-
Approval Letter(s) (PDF)
-
Printed Labeling (PDF)
-
Medical Review(s) (PDF)
-
Chemistry Review(s) (PDF)
-
Pharmacology Review(s) (PDF)
-
Statistical Review(s) (PDF)
Date created: September /9/2005
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-