Visitor Monitoring Drug History: FASLODEX
 
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Label and Approval History

Drug Name: FASLODEX
FDA Application No: (NDA) 021344
Active Ingredient(s): FULVESTRANT
Company: ASTRAZENECA
 
Label History
 
View the label approved on August 8, 2005 for FASLODEX, (NDA) 021344


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
8/2/2005 004Labeling Revision Letter
Label 
12/24/2003 001Efficacy Supplement with Clinical Data to Support Letter
Label 
4/25/2002 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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