Visitor Monitoring Drug History: HECTOROL
 
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Label and Approval History

Drug Name: HECTOROL
FDA Application No: (NDA) 021027
Active Ingredient(s): DOXERCALCIFEROL
Company: GENZYME
 
Label History
 
View the label approved on July 21, 2006 for HECTOROL, (NDA) 021027


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
7/20/2006 013Labeling Revision Letter
Label 
6/22/2005 012Labeling Revision Letter
Label 
11/26/2003 007Manufacturing Change or Addition Letter 
11/19/2002 006Manufacturing Change or Addition  
7/24/2002 005Manufacturing Change or Addition  
6/3/2002 004Manufacturing Change or Addition  
6/26/2001 001Manufacturing Change or Addition  
4/6/2000 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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