Visitor Monitoring Drug History: ENBREL
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: ENBREL
FDA Application No: (BLA) 103795
Active Ingredient(s): ETANERCEPT
Company: IMMUNEX
 
Label History
 
View the label approved on March 14, 2007 for ENBREL, (BLA) 103795


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
2/1/2007 5322Supplement Letter
Label 
6/14/2006 5286Supplement Label 
7/28/2005 5229Supplement Letter
Label 
6/28/2005 5225Supplement Letter
Label 
5/27/2005 5191Supplement Letter
Label 
9/27/2004 5184Supplement Letter
Label 
9/24/2004 5162Supplement Letter
Label 
4/30/2004 5149Supplement Letter
Patient Package Insert 
11/25/2003 5125Supplement Letter 
7/24/2003 5123Supplement Letter
Review 
10/17/2003 5110Supplement Letter 
6/5/2003 5109Supplement Letter
Label 
8/21/2003 5102Supplement Letter
Review 
10/9/2003 5099Supplement Letter 
7/24/2003 5097Supplement Letter 
7/24/2003 5055Supplement Letter 
9/12/2002 5051Supplement Letter
Label
Patient Package Insert 
1/15/2002 5034Supplement Letter
Label
Review 
1/15/2002 5016Supplement  
6/6/2000 1004Supplement Letter
Label 
5/27/1999 1001Supplement Letter
Review 
11/2/1998 0000Approval Letter
Label
Review
FDA Talk Paper 
 
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