Visitor Monitoring Drug History: IBUPROFEN
 
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Label and Approval History

Drug Name: IBUPROFEN
FDA Application No: (ANDA) 070045
Active Ingredient(s): IBUPROFEN
Company: MYLAN
 
Label History
 
Labels are not available on this site for IBUPROFEN, (ANDA) 070045
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/25/1998 025Chemistry  
2/5/1998 024Chemistry  
5/5/1994 023Chemistry in Effect  
10/10/1991 020Labeling  
10/31/1991 019Labeling Expedite  
10/31/1991 018Chemistry Expedite  
6/4/1991 017Labeling  
1/31/1990 016Chemistry  
8/30/1989 015Labeling  
1/4/1989 013Labeling  
6/21/1988 012Chemistry  
4/4/1988 009Labeling  
5/13/1988 008Chemistry  
1/24/1986 003Chemistry  
1/24/1986 002Chemistry  
9/24/1985 000Approval  
 
Therapeutic Equivalents
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