Visitor Monitoring Drug History: SARAFEM
 
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Label and Approval History

Drug Name: SARAFEM
FDA Application No: (NDA) 021860
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: WARNER CHILCOTT
 
Label History
 
View the label approved on April 9, 2007 for SARAFEM, (NDA) 021860


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
4/5/2007 001Labeling Revision Letter
Label 
5/19/2006 000Approval Letter
Label
Other Important Information from FDA 
 
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