Visitor Monitoring Drug History: MANDOL
 
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Label and Approval History

Drug Name: MANDOL
FDA Application No: (NDA) 050504
Active Ingredient(s): CEFAMANDOLE NAFATE
Company: LILLY
 
Label History
 
Labels are not available on this site for MANDOL, (NDA) 050504
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/22/2002 064Control Supplement  
3/4/2003 062Labeling Revision Letter 
1/5/1999 061Manufacturing Change or Addition  
6/18/1996 060Manufacturing Change or Addition  
7/18/2002 059Labeling Revision Letter 
3/23/1993 058Manufacturing Change or Addition  
12/31/1992 057Labeling Revision  
11/16/1981 055Labeling Revision  
9/4/1981 054Labeling Revision  
2/11/1981 053Control Supplement  
11/23/1980 052Labeling Revision  
11/20/1980 051Labeling Revision  
11/20/1980 050Labeling Revision  
11/20/1980 049Labeling Revision  
11/20/1980 048Labeling Revision  
10/28/1980 047Labeling Revision  
10/3/1980 046Labeling Revision  
7/1/1980 045Labeling Revision  
6/17/1980 044Labeling Revision  
5/28/1980 043Labeling Revision  
5/1/1980 042Labeling Revision  
5/1/1980 041Control Supplement  
4/14/1980 040Labeling Revision  
11/13/1979 039Labeling Revision  
9/10/1979 038Control Supplement  
8/1/1979 037Labeling Revision  
5/15/1979 036Labeling Revision  
8/1/1979 035New or Modified Indication  
3/21/1979 034Labeling Revision  
2/6/1979 033Labeling Revision  
1/15/1979 032Labeling Revision  
11/21/1978 031Labeling Revision  
11/15/1978 030Control Supplement  
10/14/1992 029Labeling Revision  
6/18/1993 028Labeling Revision  
6/13/1991 027Labeling Revision  
9/3/1982 026Labeling Revision  
5/10/1995 025Labeling Revision  
7/29/1982 023Labeling Revision  
3/12/1986 022Labeling Revision  
3/12/1986 021Labeling Revision  
7/15/1982 019Labeling Revision  
9/7/1984 017Package Change  
2/28/1984 016Control Supplement  
9/6/1983 014Labeling Revision  
8/24/1983 013Labeling Revision  
8/5/1983 012Labeling Revision  
6/21/1983 010Labeling Revision  
6/20/1983 009Labeling Revision  
11/19/1981 008Control Supplement  
3/23/1983 007Labeling Revision  
3/18/1983 006Labeling Revision  
2/17/1983 005Control Supplement  
2/1/1983 004Control Supplement  
12/14/1982 003Control Supplement  
11/18/1982 002Control Supplement  
11/17/1982 001Control Supplement  
9/27/1978 000Approval  
 
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