Visitor Monitoring Drug History: FLOXIN
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Label and Approval History

Drug Name: FLOXIN
FDA Application No: (NDA) 019735
Active Ingredient(s): OFLOXACIN
Company: ORTHO MCNEIL PHARM
 
Label History
 
View the label approved on June 27, 2007 for FLOXIN, (NDA) 019735


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
6/19/2007 057Labeling Revision Letter
Label 
5/16/2007 056Labeling Revision Letter
Label 
6/14/2006 055Labeling Revision Letter
Label 
1/20/2006 054Labeling Revision Letter
Label 
9/15/2004 053Labeling Revision Letter
Label 
9/15/2004 052Labeling Revision Letter
Label 
3/6/2004 051Labeling Revision Letter
Label 
10/30/2000 050Control Supplement  
12/8/1999 049Labeling Revision  
9/8/1999 048Manufacturing Change or Addition  
12/8/1999 047Labeling Revision  
3/25/1999 046Manufacturing Change or Addition  
12/8/1999 045Labeling Revision  
9/21/1998 044Labeling Revision  
6/28/1996 043Manufacturing Change or Addition  
12/19/1996 042New or Modified Indication  
11/9/1995 041Manufacturing Change or Addition  
9/22/1995 040Package Change  
8/11/1997 039Labeling Revision  
9/11/1996 038Labeling Revision  
8/8/1994 036Control Supplement  
1/9/1995 035Manufacturing Change or Addition  
12/7/1993 034Expiration Date Change  
11/30/1993 032Manufacturing Change or Addition  
11/30/1993 031Manufacturing Change or Addition  
11/30/1993 030Manufacturing Change or Addition  
7/21/1994 024Labeling Revision  
9/3/1992 023Manufacturing Change or Addition  
9/3/1992 022Manufacturing Change or Addition  
8/11/1993 021Manufacturing Change or Addition  
9/10/1992 019Formulation Revision  
12/8/1992 018Manufacturing Change or Addition  
7/14/1992 016Control Supplement Review 
9/20/1993 015Control Supplement  
6/23/1992 008Control Supplement Review 
5/15/1992 007Control Supplement Review 
12/13/1991 004Manufacturing Change or Addition Review 
2/28/1991 001Control Supplement Review 
12/28/1990 000Approval  
 
Therapeutic Equivalents
©2019 Drugs That Causes a False Positive on a Drug Test