Visitor Monitoring Drug History: FLUOXETINE
 
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Label and Approval History

Drug Name: FLUOXETINE
FDA Application No: (ANDA) 076016
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: ESI LEDERLE
 
Label History
 
Labels are not available on this site for FLUOXETINE, (ANDA) 076016
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/24/2001 000Tentative Approval Letter
Other Important Information from FDA 
 
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