Visitor Monitoring Drug History: FLUOXETINE
 
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Label and Approval History

Drug Name: FLUOXETINE
FDA Application No: (ANDA) 075207
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: MYLAN
 
Label History
 
Labels are not available on this site for FLUOXETINE, (ANDA) 075207
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/25/2007 010Labeling Revision  
5/25/2007 009Chemistry New Strength  
1/30/2002 000Approval Letter
Other Important Information from FDA 
2/26/1999 000Tentative Approval Letter
Other Important Information from FDA 
 
Therapeutic Equivalents
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