Visitor Monitoring Drug History: DRAXIMAGE MDP-10
 
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Label and Approval History

Drug Name: DRAXIMAGE MDP-10
FDA Application No: (NDA) 018035
Active Ingredient(s): TECHNETIUM TC-99M MEDRONATE KIT
Company: DRAXIMAGE
 
Label History
 
Labels are not available on this site for DRAXIMAGE MDP10, (NDA) 018035
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/27/2004 018Formulation Revision Letter 
7/3/2002 017Manufacturing Change or Addition Letter 
4/2/1999 016Labeling Revision  
4/2/1999 015Labeling Revision  
8/23/1996 014Labeling Revision  
12/30/1994 013Control Supplement  
10/31/1988 012Labeling Revision  
12/8/1988 008Control Supplement  
10/15/1979 004Labeling Revision  
4/26/1979 003Manufacturing Change or Addition  
5/29/1980 002Manufacturing Change or Addition  
5/30/1980 001Labeling Revision  
11/28/1978 000Approval Review 
 
Therapeutic Equivalents
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