Visitor Monitoring Drug History: IBUPROFEN
 
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Label and Approval History

Drug Name: IBUPROFEN
FDA Application No: (ANDA) 074978
Active Ingredient(s): IBUPROFEN
Company: ACTAVIS MID ATLANTIC
 
Label History
 
Labels are not available on this site for IBUPROFEN, (ANDA) 074978
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/25/2002 006Control Supplement  
1/29/2001 005Control Supplement  
7/24/2000 004Labeling  
11/19/1999 003Labeling  
11/19/1999 002Chemistry  
3/25/1998 000Approval Review 
1/30/1998 000Tentative Approval Review 
 
Therapeutic Equivalents
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