Visitor Monitoring Drug History: IBUPROFEN
 
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Label and Approval History

Drug Name: IBUPROFEN
FDA Application No: (ANDA) 071667
Active Ingredient(s): IBUPROFEN
Company: PLIVA
 
Label History
 
Labels are not available on this site for IBUPROFEN, (ANDA) 071667
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/11/1994 014Chemistry  
1/31/1992 013Labeling  
12/7/1989 012SBA  
2/1/1989 007Labeling  
7/5/1988 005Chemistry  
1/11/1988 003Chemistry  
1/11/1988 002Chemistry  
8/27/1987 001Chemistry  
6/18/1987 000Approval  
 
Therapeutic Equivalents
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