Visitor Monitoring Drug History: HERCEPTIN
 
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Label and Approval History

Drug Name: HERCEPTIN
FDA Application No: (BLA) 103792
Active Ingredient(s): TRASTUZUMAB
Company: GENENTECH
 
Label History
 
View the label approved on November 17, 2006 for HERCEPTIN, (BLA) 103792


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
11/16/2006 5150Supplement Letter
Label 
10/16/2003 5046Supplement Letter 
8/28/2002 5008Supplement Letter
Label 
12/11/2001 5004Supplement Letter
Label 
2/9/2000 1005Supplement Letter
Label 
9/25/1998 0000Approval Letter
Label
Review
FDA Talk Paper 
 
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