Visitor Monitoring Drug History: ORAMORPH SR
 
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Label and Approval History

Drug Name: ORAMORPH SR
FDA Application No: (NDA) 019977
Active Ingredient(s): MORPHINE SULFATE
Company: XANODYNE PHARM
 
Label History
 
Labels are not available on this site for ORAMORPH SR, (NDA) 019977
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/13/2001 007Labeling Revision Letter 
11/23/1994 005Formulation Revision  
7/13/2001 004Labeling Revision Letter 
3/11/1994 003Formulation Revision  
4/18/1994 002Control Supplement  
8/15/1991 000Approval  
 
There are no Therapeutic Equivalents
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