Visitor Monitoring Drug History: COUMADIN
 
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Label and Approval History

Drug Name: COUMADIN
FDA Application No: (NDA) 009218
Active Ingredient(s): WARFARIN SODIUM
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on August 16, 2007 for COUMADIN, (NDA) 009218


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
8/16/2007 105Labeling Revision Letter
Label 
10/4/2006 102Labeling Revision Letter
Label 
9/2/2005 101Labeling Revision Letter
Label 
5/3/2002 099Labeling Revision Letter 
5/3/2002 098Labeling Revision Letter 
2/17/2000 097Labeling Revision Review 
7/9/1999 096Labeling Revision  
12/2/1999 095Manufacturing Change or Addition  
3/31/1999 094Manufacturing Change or Addition  
12/23/1998 093Manufacturing Change or Addition  
6/1/1998 091Labeling Revision Review 
6/1/1998 090Labeling Revision Review 
4/16/1998 089Package Change  
10/29/1997 088Control Supplement  
11/23/1998 087Package Change  
6/1/1998 086Labeling Revision Review 
9/5/1996 085Labeling Revision  
11/8/1996 084Manufacturing Change or Addition  
11/18/1996 083Formulation Revision  
9/7/1995 080Labeling Revision  
3/8/1995 079Control Supplement  
2/7/1995 078Manufacturing Change or Addition  
2/7/1995 077Formulation Revision  
4/28/1995 076New or Modified Indication  
8/6/1993 075Labeling Revision  
3/31/1994 074New or Modified Indication  
6/8/1993 073Labeling Revision  
2/1/1993 072Labeling Revision  
8/20/1992 071Labeling Revision  
8/24/1993 070Formulation Revision  
12/15/1993 069Manufacturing Change or Addition  
4/11/1991 068Labeling Revision  
4/11/1991 067Labeling Revision  
5/10/1991 066Manufacturing Change or Addition  
4/25/1990 065Labeling Revision  
3/1/1990 064Labeling Revision  
3/1/1990 063Labeling Revision  
3/1/1990 062Formulation Revision  
7/1/1988 061Formulation Revision  
7/6/1987 060Labeling Revision  
7/8/1986 059Labeling Revision  
5/13/1985 056Labeling Revision  
2/25/1985 054Labeling Revision  
1/17/1985 052Labeling Revision  
7/6/1987 051Practioner Draft Labeling  
12/29/1980 042Package Change  
2/1/1980 041Control Supplement  
4/30/1980 039Package Change  
7/6/1979 037Package Change  
4/14/1978 036Control Supplement  
12/5/1977 035Control Supplement  
2/11/1977 033Formulation Revision  
9/27/1976 032Labeling Revision  
8/21/1975 031Labeling Revision  
6/8/1954 000Approval Medication Guide 
 
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