Visitor Monitoring Drug History: LEVAQUIN
 
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: LEVAQUIN
FDA Application No: (NDA) 020634
Active Ingredient(s): LEVOFLOXACIN
Company: ORTHO MCNEIL PHARM
 
Label History
 
View the label approved on June 27, 2007 for LEVAQUIN, (NDA) 020634


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 045Labeling Revision Letter
Label 
5/10/2007 044Labeling Revision Letter
Label 
9/11/2007 043Patient Population Altered Letter
Label 
5/31/2007 042Labeling Revision Letter
Label 
9/14/2007 041New Dosage Regimen Letter
Label 
6/23/2006 040Labeling Revision Letter
Label 
1/20/2006 039Labeling Revision Label 
8/4/2005 037New Dosage Regimen Letter
Label 
11/4/2004 036Labeling 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 Label 
3/5/2004 029Labeling Revision Letter
Label 
10/23/2003 028New Dosage Regimen Letter 
5/23/2003 027New or Modified Indication Letter
Label 
6/12/2002 026Control Supplement  
10/30/2002 025New or Modified Indication Letter 
4/30/2002 024Control Supplement  
1/11/2002 023Control Supplement  
12/18/2001 022Labeling Revision Letter
Label
Review 
12/18/2001 021Labeling Revision Letter
Label
Review 
6/8/2001 020Manufacturing Change or Addition  
2/13/2001 019Control Supplement  
1/4/2001 018Manufacturing Change or Addition  
9/15/2000 017Control Supplement  
12/13/2000 016Package Change  
12/18/2001 015Labeling Revision Letter
Label
Review 
8/28/2000 014Manufacturing Change or Addition  
9/8/2000 013New or Modified Indication Letter
Label 
9/8/2000 012Control Supplement Letter
Label 
2/11/2000 011Control Supplement  
9/29/1999 010Control Supplement  
2/2/2000 009Labeling Revision Letter
Review 
2/2/2000 008New or Modified Indication Letter
Review 
7/29/1999 007Labeling Revision  
7/29/1999 006Labeling Revision  
7/29/1999 005Labeling Revision  
12/17/1998 004New or Modified Indication Letter
Label
Review
Other 
3/24/1998 003Manufacturing Change or Addition  
5/11/1998 002Manufacturing Change or Addition  
1/30/1998 001Control Supplement  
12/20/1996 000Approval Review 
 
Therapeutic Equivalents
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