Drug Approval Package

 ProHance (Gadoteridol) Multipack Injection
Company:  Bracco Diagnostics, Inc.
Application No.:  021489
Approval Date: 10/09/2003

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: July 252006

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