Visitor Monitoring Drug History: FLUOXETINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: FLUOXETINE HYDROCHLORIDE
FDA Application No: (ANDA) 075755
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: ALPHAPHARM
 
Label History
 
View the label approved on June 4, 2004 for FLUOXETINE HYDROCHLORIDE, (ANDA) 075755


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
5/3/2002 001Control Supplement  
8/2/2001 000Approval Letter
Label
Review
Other Important Information from FDA 
6/29/2001 000Tentative Approval Letter
Label
Review
Other Important Information from FDA 
 
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