Drug Approval Package
-
Elaprase (Indursulfase) Injection
Company: Shire Human Genetic Therapies, Inc.
Application No.: 125151
Approval Date: 07/24/2006
-
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: September 26, 2006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
-