Visitor Monitoring Drug History: INDOCIN SR
 
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Label and Approval History

Drug Name: INDOCIN SR
FDA Application No: (NDA) 018185
Active Ingredient(s): INDOMETHACIN
Company: MERCK
 
Label History
 
Labels are not available on this site for INDOCIN SR, (NDA) 018185
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/11/2001 053Labeling Revision  
10/7/1997 050Manufacturing Change or Addition  
3/1/1996 049Manufacturing Change or Addition  
10/31/2001 048Labeling Revision  
10/24/1994 047Labeling Revision  
9/13/1994 046Labeling Revision  
9/14/1994 045Labeling Revision  
8/18/1994 044Control Supplement  
12/30/1994 043Control Supplement  
9/14/1994 042Labeling Revision  
9/26/1994 041Labeling Revision  
5/25/1989 038Labeling Revision  
1/6/1989 037Labeling Revision  
1/9/1989 035Labeling Revision  
3/10/1988 034Control Supplement  
1/6/1989 033Labeling Revision  
2/10/1989 031Labeling Revision  
6/3/1988 030Labeling Revision  
9/19/1986 026Labeling Revision  
8/15/1986 024Labeling Revision  
7/23/1985 022Labeling Revision  
11/27/1984 021Labeling Revision  
9/30/1985 020Manufacturing Change or Addition  
2/21/1985 019Manufacturing Change or Addition  
2/21/1985 018Manufacturing Change or Addition  
11/20/1984 017Manufacturing Change or Addition  
10/3/1984 016Manufacturing Change or Addition  
11/27/1984 015Labeling Revision  
5/3/1984 014Manufacturing Change or Addition  
6/25/1984 013Manufacturing Change or Addition  
1/6/1986 011Labeling Revision  
10/31/1983 008Labeling Revision  
10/5/1984 007Control Supplement  
2/1/1983 006Labeling Revision  
2/1/1983 005Labeling Revision  
10/19/1982 004Labeling Revision  
2/1/1983 002Control Supplement  
2/23/1982 000Approval  
 
Therapeutic Equivalents
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