Visitor Monitoring Drug History: CHRONULAC
 
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Label and Approval History

Drug Name: CHRONULAC
FDA Application No: (NDA) 017884
Active Ingredient(s): LACTULOSE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for CHRONULAC, (NDA) 017884
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/2/1993 022Control Supplement  
4/13/1992 021Manufacturing Change or Addition  
2/22/1990 019Manufacturing Change or Addition  
12/9/1988 018Package Change  
5/16/1989 017Manufacturing Change or Addition  
5/27/1988 016Control Supplement  
12/7/1988 015Package Change  
3/9/1987 014Manufacturing Change or Addition  
2/28/1984 013Control Supplement  
1/21/1983 011Control Supplement  
10/22/1981 010Labeling Revision  
10/22/1981 009Expiration Date Change  
10/3/1980 008Labeling Revision  
7/7/1980 007Package Change  
12/28/1979 006Labeling Revision  
3/4/1980 005Control Supplement  
12/28/1979 004Package Change  
7/29/1980 003Control Supplement  
12/28/1979 002Control Supplement  
12/28/1979 001Package Change  
6/20/1979 000Approval  
 
Therapeutic Equivalents
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