Drug Approval Package

AdreView (Iobenguane I 123) Injection
Company: GE Healthcare
Application No.:  022290
Approval Date: 09/19/2008

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Approval Letter(s) (PDF) 

• Summary Review (PDF) 

• Officer/Employee List (PDF) 

• Office Director Memo (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) 

• Proprietary Name Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: October 23, 2008

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