Visitor Monitoring Drug History: IBUPROFEN
 
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Label and Approval History

Drug Name: IBUPROFEN
FDA Application No: (ANDA) 074931
Active Ingredient(s): IBUPROFEN
Company: LEINER
 
Label History
 
View the label approved on June 7, 2004 for IBUPROFEN, (ANDA) 074931


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
7/24/2000 009Facility Addition  
5/3/2000 007Facility Addition  
5/3/2000 006Facility Addition  
7/24/2000 005Labeling  
8/16/1999 002Chemistry  
8/16/1999 001Chemistry  
7/20/1998 000Approval Letter
Label
Review 
 
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