Visitor Monitoring Drug History: MACRODANTIN
 
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Label and Approval History

Drug Name: MACRODANTIN
FDA Application No: (NDA) 016620
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
Company: PROCTER AND GAMBLE
 
Label History
 
View the label approved on September 19, 2007 for MACRODANTIN, (NDA) 016620


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/14/2007 067Labeling Revision Letter
Label 
3/29/2004 065Labeling Revision Letter
Label 
2/4/2003 064Labeling Revision Letter 
10/21/1998 063Control Supplement  
7/16/1997 062Labeling Revision  
3/27/1997 061Labeling Revision  
7/30/1996 060Manufacturing Change or Addition  
3/7/1996 059Control Supplement  
2/17/1998 058Labeling Revision  
8/9/1993 057Control Supplement  
2/17/1998 056Labeling Revision  
12/8/1992 055Control Supplement  
12/8/1992 054Formulation Revision  
12/8/1992 053Package Change  
12/8/1992 052Manufacturing Change or Addition  
4/10/1991 051Control Supplement  
7/9/1990 050Package Change  
9/11/1990 049Manufacturing Change or Addition  
1/3/1989 047Manufacturing Change or Addition Review 
5/13/1988 045Labeling Revision Review 
5/19/1993 039Labeling Revision  
7/9/1984 038Manufacturing Change or Addition  
6/2/1983 037Manufacturing Change or Addition  
5/18/1993 036Labeling Revision  
5/13/1982 035Package Change  
12/12/1980 032Labeling Revision  
10/15/1982 031Labeling Revision  
8/14/1980 030Formulation Revision  
5/20/1980 028Package Change  
7/16/1979 027Manufacturing Change or Addition  
12/18/1979 026Labeling Revision  
7/26/1979 025Package Change  
7/28/1978 023Labeling Revision  
5/13/1977 021Control Supplement  
3/21/1977 020Control Supplement Review 
11/22/1976 019Package Change Review 
7/21/1976 018Package Change Review 
7/21/1976 017Manufacturing Change or Addition Review 
7/15/1976 016Package Change Review 
6/5/1970 000Approval  
 
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