Visitor Monitoring Drug History: INDOCIN
 
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Label and Approval History

Drug Name: INDOCIN
FDA Application No: (NDA) 018332
Active Ingredient(s): INDOMETHACIN
Company: MERCK
 
Label History
 
View the label approved on February 2, 2007 for INDOCIN, (NDA) 018332


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 030Labeling Revision Letter
Label 
1/26/2006 029Labeling Revision Label 
3/24/2005 028Labeling Revision Letter 
11/26/2001 023Labeling Revision  
4/28/1998 022Control Supplement  
10/31/2001 021Labeling Revision  
10/24/1994 020Labeling Revision  
9/13/1994 019Labeling Revision  
12/30/1994 018Control Supplement  
9/26/1994 017Labeling Revision  
5/25/1989 014Labeling Revision  
1/6/1989 013Labeling Revision  
1/9/1989 011Labeling Revision  
3/10/1988 010Control Supplement  
1/6/1989 009Labeling Revision  
6/3/1988 006Labeling Revision  
8/15/1986 004Labeling Revision  
9/19/1986 003Labeling Revision  
6/4/1986 002Package Change  
1/6/1986 001Labeling Revision  
10/10/1985 000Approval  
 
Therapeutic Equivalents
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