Visitor Monitoring Drug History: REMICADE
 
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Label and Approval History

Drug Name: REMICADE
FDA Application No: (BLA) 103772
Active Ingredient(s): INFLIXIMAB
Company: CENTOCOR INC
 
Label History
 
View the label approved on July 5, 2007 for REMICADE, (BLA) 103772


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
6/12/2007 5189Supplement Letter
Label 
8/11/2006 5167Supplement Letter
Label 
8/11/2006 5166Supplement Letter
Label 
12/8/2006 5163Supplement Letter
Label 
4/19/2007 5160Supplement Letter
Label 
10/13/2006 5145Supplement Letter
Label 
5/19/2006 5138Supplement Letter
Label 
1/31/2007 5129Supplement Letter
Label 
9/15/2005 5113Supplement Letter
Label 
4/5/2005 5092Supplement Letter
Label 
12/17/2004 5090Supplement Letter 
5/18/2005 5089Supplement Letter
Label 
12/17/2004 5077Supplement Letter
Label 
9/29/2004 5073Supplement Letter
Label
Patient Package Insert 
7/29/2004 5058Supplement Letter
Label 
9/3/2003 5056Supplement Letter 
4/1/2003 5032Supplement Letter 
9/3/2003 5020Supplement Letter 
6/28/2002 5012Supplement Letter
Label 
2/27/2002 5004Supplement Letter
Label 
12/29/2000 1007Supplement Letter
Label
Review 
11/10/1999 1004Supplement Letter
Label
Review 
8/24/1998 0000Approval Letter
Label
Review
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