Drug Approval Package
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Helicosol
(C-urea) Lyophilized Powder
Company: Metabolic Solutions, Inc.
Application No.: 21-092
Approval Date: 12/17/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Correspondence (PDF)
Date created: October 11, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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