Visitor Monitoring Drug History: LACTULOSE
 
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Label and Approval History

Drug Name: LACTULOSE
FDA Application No: (ANDA) 073591
Active Ingredient(s): LACTULOSE
Company: ROXANE
 
Label History
 
Labels are not available on this site for LACTULOSE, (ANDA) 073591
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/23/2002 015Control Supplement  
11/30/2000 014Package Change  
9/2/1998 013Chemistry  
3/27/2000 012Chemistry  
12/11/1996 010Chemistry  
12/11/1996 009Chemistry  
9/20/1996 008Chemistry  
9/20/1996 007Labeling  
9/20/1996 006Chemistry  
8/28/1996 005Chemistry  
8/18/1995 004Chemistry  
2/8/1995 003Labeling  
8/18/1995 002Labeling  
8/18/1995 001Chemistry  
5/29/1992 000Approval  
 
Therapeutic Equivalents
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