Visitor Monitoring Drug History: INDOCIN
 
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Label and Approval History

Drug Name: INDOCIN
FDA Application No: (NDA) 017814
Active Ingredient(s): INDOMETHACIN
Company: MERCK
 
Label History
 
View the label approved on February 2, 2007 for INDOCIN, (NDA) 017814


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 040Labeling Revision Letter
Label 
1/26/2006 039Labeling Revision Label 
3/24/2005 038Labeling Revision Letter 
2/4/2000 035Manufacturing Change or Addition  
10/29/1997 032Control Supplement  
11/3/1997 031Control Supplement  
10/6/1999 030Control Supplement  
10/3/1997 029Control Supplement  
10/31/2001 028Labeling Revision  
10/24/1994 027Labeling Revision  
9/13/1994 026Labeling Revision  
12/30/1994 025Control Supplement  
9/26/1994 024Labeling Revision  
5/23/1989 021Labeling Revision  
1/6/1989 020Labeling Revision  
1/9/1989 018Labeling Revision  
3/10/1988 017Control Supplement  
1/6/1989 016Labeling Revision  
6/3/1988 013Labeling Revision  
9/19/1986 011Labeling Revision  
8/15/1986 010Labeling Revision  
6/4/1986 009Labeling Revision  
1/6/1986 005Labeling Revision  
7/23/1985 004Labeling Revision  
11/27/1984 002Labeling Revision  
8/13/1984 000Approval  
 
Therapeutic Equivalents
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