Visitor Monitoring Drug History: CEPHULAC
 
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Label and Approval History

Drug Name: CEPHULAC
FDA Application No: (NDA) 017657
Active Ingredient(s): LACTULOSE
Company: SANOFI AVENTIS US
 
Label History
 
Labels are not available on this site for CEPHULAC, (NDA) 017657
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/9/1993 032Control Supplement  
4/13/1992 031Manufacturing Change or Addition  
4/5/1991 030Package Change  
2/22/1990 028Manufacturing Change or Addition  
12/9/1988 027Package Change  
5/16/1989 026Manufacturing Change or Addition  
9/18/1987 025Labeling Revision  
5/27/1988 024Control Supplement  
12/7/1988 023Package Change  
3/9/1987 022Manufacturing Change or Addition  
5/31/1984 021Control Supplement  
1/14/1983 019Control Supplement  
10/22/1981 018Labeling Revision  
10/22/1981 017Expiration Date Change  
11/13/1980 016Labeling Revision  
10/3/1980 015Labeling Revision  
8/20/1980 014Package Change  
6/20/1980 013Labeling Revision  
3/4/1980 012Control Supplement  
12/27/1979 011Control Supplement  
7/29/1980 009Control Supplement  
11/21/1978 008Labeling Revision  
5/4/1979 007Package Change  
12/8/1977 006Labeling Revision  
12/8/1977 005Package Change  
11/3/1977 004Expiration Date Change  
5/12/1977 003Labeling Revision  
5/12/1977 002Package Change  
6/27/1980 001General Efficacy (MarkIV)  
3/25/1976 000Approval  
 
Therapeutic Equivalents
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