Visitor Monitoring Drug History: INDOCIN
 
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Label and Approval History

Drug Name: INDOCIN
FDA Application No: (NDA) 016059
Active Ingredient(s): INDOMETHACIN
Company: MERCK
 
Label History
 
View the label approved on February 2, 2007 for INDOCIN, (NDA) 016059


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
1/30/2007 097Labeling Revision Letter
Label 
1/26/2006 096Labeling Revision Label 
3/24/2005 095Labeling Revision Letter 
12/1/1997 090Control Supplement  
3/1/1996 089Manufacturing Change or Addition  
10/31/2001 088Labeling Revision  
10/24/1994 087Labeling Revision  
9/13/1994 086Labeling Revision  
8/18/1994 085Control Supplement  
12/30/1994 084Control Supplement  
9/14/1994 083Labeling Revision  
9/26/1994 082Labeling Revision  
4/4/1991 079Manufacturing Change or Addition  
5/25/1989 078Labeling Revision  
1/6/1989 077Labeling Revision  
1/9/1989 075Labeling Revision  
5/3/1988 074Manufacturing Change or Addition  
1/6/1989 073Labeling Revision  
6/3/1988 071Labeling Revision  
9/22/1986 068Labeling Revision  
8/15/1986 067Labeling Revision  
6/4/1986 065Labeling Revision  
8/15/1986 062Labeling Revision  
7/23/1985 061Labeling Revision  
11/27/1984 060Labeling Revision  
12/6/1984 059Labeling Revision  
6/25/1984 058Manufacturing Change or Addition  
5/11/1983 054Manufacturing Change or Addition  
1/19/1983 052Package Change  
11/18/1983 051Labeling Revision  
1/31/1983 050Control Supplement  
8/13/1984 047Package Change  
3/3/1982 046Manufacturing Change or Addition  
1/6/1986 045General Efficacy (MarkIV)  
4/9/1981 044Control Supplement  
9/27/1980 043Labeling Revision  
7/29/1983 042Package Change  
5/28/1981 041Labeling Revision  
10/26/1979 040Labeling Revision  
8/8/1979 039Labeling Revision  
9/24/1979 038Manufacturing Change or Addition  
1/29/1979 036Control Supplement  
2/23/1978 035Control Supplement  
10/26/1979 034Package Change  
10/11/1978 033Control Supplement  
12/22/1977 031Labeling Revision  
6/29/1976 030Labeling Revision  
10/7/1981 029Labeling Revision  
8/27/1976 028Control Supplement  
6/10/1965 000Approval  
 
Therapeutic Equivalents
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