Drug Approval Package

Helicosol (C-urea) Lyophilized Powder
Company:  Metabolic Solutions, Inc.
Application No.:  21-092
Approval Date: 12/17/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Chemistry Review(s) (PDF)   

• Pharmacology Review(s) (PDF)   

• Statistical Review(s) (PDF)  

• Clinical and Statistical Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: October 11, 2001

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