Visitor Monitoring Drug History: HELICOSOL
 
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Label and Approval History

Drug Name: HELICOSOL
FDA Application No: (NDA) 021092
Active Ingredient(s): UREA, C-13
Company: METABOLIC SOLUTIONS
 
Label History
 
View the label approved on December 17, 1999 for HELICOSOL, (NDA) 021092


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/20/2000 001Manufacturing Change or Addition  
12/17/1999 000Approval Letter
Label
Review 
 
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