Visitor Monitoring Drug History: ISOSORBIDE MONONITRATE
 
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Label and Approval History

Drug Name: ISOSORBIDE MONONITRATE
FDA Application No: (ANDA) 075155
Active Ingredient(s): ISOSORBIDE MONONITRATE
Company: KREMERS URBAN
 
Label History
 
Labels are not available on this site for ISOSORBIDE MONONITRATE, (ANDA) 075155
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/26/2001 020Manufacturing Revision  
6/30/2000 018Supplier Addition  
8/4/2000 017Control Supplement  
8/4/2000 016Facility Addition  
12/14/1999 014Facility Addition  
8/4/2000 013Labeling  
8/4/2000 012Chemistry  
8/4/2000 011Chemistry  
8/4/2000 010Chemistry New Strength  
7/27/1999 008Labeling  
7/27/1999 007Chemistry  
7/27/1999 006Chemistry  
1/13/2000 005Chemistry  
1/13/2000 004Chemistry  
1/13/2000 003Labeling  
1/13/2000 002Chemistry New Strength  
5/14/1999 001Chemistry  
10/30/1998 000Approval Letter 
 
Therapeutic Equivalents
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