Visitor Monitoring Drug History: OMNIPRED
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: OMNIPRED
FDA Application No: (NDA) 017469
Active Ingredient(s): PREDNISOLONE ACETATE
Company: ALCON
 
Label History
 
View the label approved on October 15, 2007 for OMNIPRED, (NDA) 017469


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
10/11/2007 040Labeling Revision Letter
Label 
5/15/2006 038Labeling Revision Label 
5/15/2006 035Labeling Revision Letter
Label 
4/17/2003 031Labeling Revision Letter
Label 
12/11/2002 030Control Supplement  
12/4/2002 029Control Supplement  
5/16/2000 028Manufacturing Change or Addition  
8/17/1999 027Control Supplement  
4/5/1999 026Manufacturing Change or Addition  
3/9/1999 025Control Supplement  
10/6/1998 024Package Change  
8/4/1998 023Control Supplement  
6/27/1997 022Control Supplement  
3/18/1996 021Control Supplement  
3/5/1996 020Control Supplement  
11/1/1995 019Control Supplement  
8/29/1995 018Comparative Efficacy Claim  
11/1/1995 017Control Supplement  
6/13/1995 016Package Change  
4/10/1991 015Package Change  
8/22/1991 014Labeling Revision  
3/2/1988 013Manufacturing Change or Addition  
3/12/1986 012Control Supplement  
3/6/1989 011Labeling Revision  
5/25/1982 010Control Supplement  
5/24/1979 008Manufacturing Change or Addition  
8/24/1977 007Labeling Revision  
4/6/1977 006Control Supplement  
4/6/1977 005Control Supplement  
4/6/1977 004Control Supplement  
4/6/1977 003Control Supplement  
12/5/1974 001Labeling Revision  
7/10/1973 000Approval  
 
Therapeutic Equivalents
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