Visitor Monitoring Drug History: OCUFEN
 
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Label and Approval History

Drug Name: OCUFEN
FDA Application No: (NDA) 019404
Active Ingredient(s): FLURBIPROFEN SODIUM
Company: ALLERGAN
 
Label History
 
View the label approved on August 28, 2003 for OCUFEN, (NDA) 019404


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
4/12/2002 021Control Supplement  
8/25/2003 020Package Change Letter
Label 
11/27/2001 019Control Supplement  
12/4/2001 018Manufacturing Change or Addition  
8/17/2001 017Manufacturing Change or Addition Label 
4/12/2001 016Manufacturing Change or Addition  
7/30/2001 014Labeling Revision Label 
10/2/2000 013Manufacturing Change or Addition  
4/29/1998 012Control Supplement  
4/18/1997 011Control Supplement  
6/10/1996 010Control Supplement  
8/3/1995 009Control Supplement  
4/21/1992 007Labeling Revision  
4/13/1989 005Labeling Revision  
7/25/1990 001Control Supplement  
12/31/1986 000Approval  
 
Therapeutic Equivalents
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