Visitor Monitoring Drug History: TARCEVA
 
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Label and Approval History

Drug Name: TARCEVA
FDA Application No: (NDA) 021743
Active Ingredient(s): ERLOTINIB HYDROCHLORIDE
Company: OSI PHARMS
 
Label History
 
View the label approved on May 1, 2007 for TARCEVA, (NDA) 021743


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
4/27/2007 007Labeling Revision Letter
Label 
11/2/2005 003New or Modified Indication Letter
Label 
11/18/2004 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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