Visitor Monitoring Drug History: TAMIFLU
 
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Label and Approval History

Drug Name: TAMIFLU
FDA Application No: (NDA) 021246
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
Company: ROCHE
 
Label History
 
View the label approved on October 10, 2007 for TAMIFLU, (NDA) 021246


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
10/5/2007 028Labeling Revision Letter
Label 
7/2/2007 027Formulation Revision Letter
Label 
11/13/2006 021Labeling Revision Letter
Label
Patient Package Insert 
12/21/2005 017Patient Population Altered Letter
Label
Patient Package Insert 
6/24/2004 010Labeling Revision Letter
Label
Review 
4/26/2002 007Labeling Revision Letter
Label
Review
Other Important Information from FDA 
3/4/2002 006Control Supplement Review 
11/5/2001 004Labeling Revision Label
Review 
7/24/2001 003Labeling Revision Label
Review 
7/5/2001 002Control Supplement Review 
7/24/2001 001Labeling Revision Label
Review 
12/14/2000 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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