Visitor Monitoring Drug History: URSO 250
 
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Label and Approval History

Drug Name: URSO 250
FDA Application No: (NDA) 020675
Active Ingredient(s): URSODIOL
Company: AXCAN SCANDIPHARM
 
Label History
 
View the label approved on July 28, 2004 for URSO 250, (NDA) 020675


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
9/24/2004 011Labeling Revision Letter 
7/21/2004 009New Dosage Regimen Letter
Label 
3/8/2001 007Labeling Revision Letter 
3/8/2001 006Manufacturing Change or Addition Letter 
1/30/2001 005Package Change  
2/8/2000 004Manufacturing Change or Addition  
2/2/2001 002Package Change  
4/17/1998 001Manufacturing Change or Addition  
12/10/1997 000Approval Review 
 
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