Briefcases -- MDL 1943 LEVAQUIN (levofloxacin) Products Liability Litigation (USDC Minnesota) -- Levaguin FDA Approval History

Documents: Levaguin FDA Approval History

Label and Approval History


Drug Name(s) LEVAQUIN
FDA Application No. (NDA) 020634
Active Ingredient(s) LEVOFLOXACIN
Company JANSSEN PHARMS

 

Go to Approval History
Label Information

What information does a label include?

Note: Not all labels are available in electronic format from FDA.

View the label approved on 05/23/2014 (PDF) for NDA no. 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
NDA 020634

Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.


Click on a column header to re-sort the table:  

Action
Date

Supplement
Number

Approval
Type
Letters,
Reviews,
Labels,
Patient Package Insert  
Note
05/23/2014  066  Labeling Revision   Label (PDF)
Letter (PDF)  
 
08/14/2013  065  Labeling Revision   Label (PDF)
Letter (PDF)  
 
04/27/2012  061  Efficacy Supplement with Clinical Data to Support   Label (PDF)
Letter (PDF)
Review  
 
10/11/2011  064  Labeling Revision   Label (PDF)
Letter (PDF)
Review (PDF)  
 
10/11/2011  062  Labeling Revision   Label (PDF)
Letter (PDF)
Review (PDF)  
 
06/09/2011  059  Labeling Revision   Label (PDF)
Letter (PDF)  
 
02/25/2011  058  Labeling Revision   Label (PDF)
Letter (PDF)  
 
04/27/2009  053  Labeling Revision   Label (PDF)
Letter (PDF)  
 
03/12/2009  054  Labeling Revision   Letter (PDF)   Label is not available
on this site.  
10/03/2008  052  Labeling Revision   Label (PDF)
Letter (PDF)  
 
05/05/2008  047  Patient Population Altered   Letter (PDF)
Summary Review (PDF)  
Label is not available
on this site.  
04/16/2008  051  Labeling Revision   Label (PDF)
Letter (PDF)  
 
12/13/2007  050  Labeling Revision   Label (PDF)
Letter (PDF)  
 
11/16/2007  049  Labeling Revision   Label (PDF)
Letter (PDF)  
 
11/15/2007  048  Labeling Revision   Label (PDF)
Letter (PDF)  
 
09/14/2007  041  New Dosage Regimen   Label (PDF)
Letter (PDF)  
 
09/11/2007  043  Patient Population Altered   Label (PDF)
Letter (PDF)  
 
06/19/2007  045  Labeling Revision   Label (PDF)
Letter (PDF)  
 
05/31/2007  042  Labeling Revision   Label (PDF)
Letter (PDF)  
 
05/10/2007  044  Labeling Revision   Label (PDF)
Letter (PDF)  
 
06/23/2006  040  Labeling Revision   Label (PDF)
Letter (PDF)  
 
01/20/2006  039  Labeling Revision   Label (PDF)    
08/04/2005  037  New Dosage Regimen   Label (PDF)
Letter (PDF)  
 
11/24/2004  035  New or Modified Indication   Label (PDF)
Letter (PDF)  
 
11/04/2004  036  Labeling Revision   Label (PDF)
Letter (PDF)  
 
09/14/2004  034  Labeling Revision   Label (PDF)
Letter (PDF)
Review (PDF)  
 
09/14/2004  033  Labeling Revision   Label (PDF)
Letter (PDF)
Review (PDF)  
 
07/14/2004  030  New or Modified Indication   Label (PDF)    
03/05/2004  029  Labeling Revision   Label (PDF)
Letter (PDF)  
 
10/23/2003  028  New Dosage Regimen   Letter (PDF)
Review (PDF)  
Label is not available
on this site.  
05/23/2003  027  New or Modified Indication   Label (PDF)
Letter (PDF)
Review (PDF)  
 
10/30/2002  025  New or Modified Indication   Letter (PDF)   Label is not available
on this site.  
06/12/2002  026  Control Supplement     This supplement type does
not usually require new labeling.  
04/30/2002  024  Control Supplement     This supplement type does
not usually require new labeling.  
01/11/2002  023  Control Supplement     This supplement type does
not usually require new labeling.  
12/18/2001  022  Labeling Revision   Label (PDF)
Letter (PDF)
Review  
 
12/18/2001  021  Labeling Revision   Label (PDF)
Letter (PDF)
Review  
 
12/18/2001  015  Labeling Revision   Label (PDF)
Letter (PDF)
Review  
 
06/08/2001  020  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
02/13/2001  019  Control Supplement     This supplement type does
not usually require new labeling.  
01/04/2001  018  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
12/13/2000  016  Package Change     Label is not available
on this site.  
09/15/2000  017  Control Supplement     This supplement type does
not usually require new labeling.  
09/08/2000  013  New or Modified Indication   Label (PDF)
Letter (PDF)  
 
09/08/2000  012  Control Supplement   Label (PDF)
Letter (PDF)  
This supplement type does
not usually require new labeling.  
08/28/2000  014  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
02/11/2000  011  Control Supplement     This supplement type does
not usually require new labeling.  
02/02/2000  009  Labeling Revision   Letter (PDF)   Label is not available
on this site.  
02/02/2000  008  New or Modified Indication   Letter (PDF)
Review  
Label is not available
on this site.  
09/29/1999  010  Control Supplement     This supplement type does
not usually require new labeling.  
07/29/1999  007  Labeling Revision     Label is not available
on this site.  
07/29/1999  006  Labeling Revision     Label is not available
on this site.  
07/29/1999  005  Labeling Revision     Label is not available
on this site.  
12/17/1998  004  New or Modified Indication   Label (PDF)
Letter (PDF)
Review  
 
05/11/1998  002  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
03/24/1998  003  Manufacturing Change or Addition     This supplement type does
not usually require new labeling.  
01/30/1998  001  Control Supplement     This supplement type does
not usually require new labeling.  
12/20/1996  000  Approval   Review   Label is not available
on this site.  

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Levquin FDA Approval History