Visitor Monitoring Drug History: INDOMETHACIN
 
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Label and Approval History

Drug Name: INDOMETHACIN
FDA Application No: (ANDA) 071148
Active Ingredient(s): INDOMETHACIN
Company: PLIVA
 
Label History
 
Labels are not available on this site for INDOMETHACIN, (ANDA) 071148
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/13/2002 015Labeling  
6/5/2001 014Control Supplement  
7/7/2000 013Facility Addition  
7/2/1996 012Labeling  
4/29/1996 011Labeling  
7/15/1994 010Labeling  
5/11/1994 008Chemistry  
11/8/1991 007Labeling  
4/1/1991 006Labeling  
2/24/1989 005Labeling  
2/8/1989 004Labeling  
11/23/1992 001Chemistry  
3/18/1987 000Approval  
 
Therapeutic Equivalents
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