Visitor Monitoring Drug History: LEVAQUIN
 
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: LEVAQUIN
FDA Application No: (NDA) 020635
Active Ingredient(s): LEVOFLOXACIN
Company: ORTHO MCNEIL PHARM
 
Label History
 
View the label approved on June 27, 2007 for LEVAQUIN, (NDA) 020635


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 048Labeling Revision Letter
Label 
5/10/2007 047Labeling Revision Letter
Label 
9/11/2007 046Patient Population Altered Letter
Label 
5/31/2007 045Labeling Revision Letter
Label 
9/14/2007 044New Dosage Regimen Letter
Label 
6/23/2006 043Labeling Revision Letter
Label 
1/20/2006 042Labeling Revision Label 
8/4/2005 038New Dosage Regimen Letter
Label 
11/4/2004 037Labeling Revision Letter
Label 
11/24/2004 035New or Modified Indication Letter
Label 
9/14/2004 034Labeling Revision Letter
Label 
9/14/2004 033Labeling Revision Letter
Label 
7/14/2004 030New or Modified Indication Letter 
3/5/2004 029Labeling Revision Letter
Label 
10/23/2003 027New Dosage Regimen Letter 
5/23/2003 026New or Modified Indication Letter
Label 
11/21/2002 025Package Change  
11/6/2002 024Manufacturing Change or Addition  
10/30/2002 022New or Modified Indication Letter 
1/11/2002 021Control Supplement  
12/18/2001 020Labeling Revision Letter
Label
Review 
12/18/2001 019Labeling Revision Letter
Label
Review 
9/25/2001 018Manufacturing Change or Addition  
1/4/2001 017Manufacturing Change or Addition  
10/27/2000 016Manufacturing Change or Addition  
9/15/2000 015Control Supplement  
12/13/2000 014Package Change  
9/8/2000 013Package Change  
12/18/2001 012Labeling Revision Letter
Label
Review 
9/8/2000 011Control Supplement  
9/8/2000 010New or Modified Indication Letter
Label 
9/29/1999 009Control Supplement  
2/2/2000 008Labeling Revision Review 
2/2/2000 007New or Modified Indication Letter
Review 
7/29/1999 006Labeling Revision  
7/29/1999 005Labeling Revision  
7/29/1999 004Labeling Revision  
12/17/1998 003New or Modified Indication Letter
Label
Review 
10/20/1998 002Control Supplement  
4/8/1997 001Control Supplement  
12/20/1996 000Approval Review 
 
There are no Therapeutic Equivalents
©2019 Drugs That Causes a False Positive on a Drug Test