Visitor Monitoring Drug History: REMODULIN
 
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Label and Approval History

Drug Name: REMODULIN
FDA Application No: (NDA) 021272
Active Ingredient(s): TREPROSTINIL SODIUM
Company: UNITED THERAP
 
Label History
 
View the label approved on March 22, 2006 for REMODULIN, (NDA) 021272


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
3/20/2006 005Accelerated Approval Letter
Label 
1/20/2006 003Labeling Revision Letter 
11/24/2004 002New Route of Administration  
5/21/2002 000Approval Letter
Label
Review 
 
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