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)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: September 26, 2006

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