Visitor Monitoring Drug History: FLUOXETINE
 
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Label and Approval History

Drug Name: FLUOXETINE
FDA Application No: (ANDA) 075465
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
Company: DR REDDYS LABS INC
 
Label History
 
View the label approved on June 4, 2004 for FLUOXETINE, (ANDA) 075465


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
1/29/2002 000Approval Letter
Letter
Label
Review
Other Important Information from FDA 
6/26/2001 000Tentative Approval Letter
Letter
Label
Review
Other Important Information from FDA 
 
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