Visitor Monitoring Drug History: FEMARA
 
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Label and Approval History

Drug Name: FEMARA
FDA Application No: (NDA) 020726
Active Ingredient(s): LETROZOLE
Company: NOVARTIS PHARMS
 
Label History
 
View the label approved on April 20, 2007 for FEMARA, (NDA) 020726


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
4/11/2007 014Labeling Revision Letter
Label 
6/26/2006 013Labeling Revision Letter 
12/28/2005 012New or Modified Indication Letter
Label 
10/29/2004 011New or Modified Indication Letter
Label 
1/17/2003 008Efficacy Supplement with Clinical Data to Support Letter
Label 
1/10/2002 007Manufacturing Change or Addition  
1/10/2001 006New or Modified Indication Letter
Label
Review 
2/26/2003 005Efficacy Supplement with Clinical Data to Support Letter
Label 
5/23/2000 004Manufacturing Change or Addition  
2/5/2001 003Control Supplement  
4/22/1999 002Package Change  
3/17/1999 001Manufacturing Change or Addition  
7/25/1997 000Approval Label
Review 
 
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