Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020634
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVAQUIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription AB Yes No
LEVAQUIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription AB Yes No
LEVAQUIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/20/1996 ORIG-1 Approval Type 3 - New Dosage Form N/A Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020634_levaquin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/08/2017 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020634Orig1s068,020635Orig1s074,021721Orig1s035ltr.pdf
07/26/2016 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf
05/23/2014 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf
08/14/2013 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf
10/11/2011 SUPPL-64 REMS-Modified Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf
10/11/2011 SUPPL-62 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf
04/27/2012 SUPPL-61 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm
06/09/2011 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf
02/25/2011 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf
03/12/2009 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf
04/27/2009 SUPPL-53 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf
10/03/2008 SUPPL-52 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf
04/16/2008 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf
12/13/2007 SUPPL-50 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf
11/16/2007 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf
11/15/2007 SUPPL-48 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf
05/05/2008 SUPPL-47 Efficacy-New Patient Population Letter (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf
06/19/2007 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf
05/10/2007 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf
09/11/2007 SUPPL-43 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf
05/31/2007 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf
09/14/2007 SUPPL-41 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf
06/23/2006 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf
01/20/2006 SUPPL-39 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf
08/04/2005 SUPPL-37 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf
11/04/2004 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf
11/24/2004 SUPPL-35 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf
09/14/2004 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S034_Levaquin.pdf
09/14/2004 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S033_Levaquin.pdf
07/14/2004 SUPPL-30 Efficacy-New Indication Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s030,20635s030lbl.pdf
03/05/2004 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf
10/23/2003 SUPPL-28 Efficacy-New Dosing Regimen Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S028_LEVAQUIN.pdf
05/23/2003 SUPPL-27 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S027_LEVAQUIN.pdf
06/12/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2002 SUPPL-25 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf
04/30/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2001 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
12/18/2001 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
06/08/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/13/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/15/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2000 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/2001 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
08/28/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/08/2000 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf
09/08/2000 SUPPL-12 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf
02/11/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-9 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm
02/02/2000 SUPPL-8 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm
07/29/1999 SUPPL-7 Labeling

Label is not available on this site.

07/29/1999 SUPPL-6 Labeling

Label is not available on this site.

07/29/1999 SUPPL-5 Labeling

Label is not available on this site.

12/17/1998 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm
03/24/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/11/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/30/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/08/2017 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020634s068,020635s074,021721s035lbl.pdf
07/26/2016 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf
05/23/2014 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf
08/14/2013 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf
04/27/2012 SUPPL-61 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf
10/11/2011 SUPPL-64 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
10/11/2011 SUPPL-62 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
10/11/2011 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
06/09/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf
02/25/2011 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf
04/27/2009 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf
04/27/2009 SUPPL-53 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf
10/03/2008 SUPPL-52 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf
04/16/2008 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf
12/13/2007 SUPPL-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf
11/16/2007 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf
11/15/2007 SUPPL-48 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf
09/14/2007 SUPPL-41 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf
09/11/2007 SUPPL-43 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf
06/19/2007 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf
05/31/2007 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf
05/10/2007 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf
06/23/2006 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf
01/20/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf
08/04/2005 SUPPL-37 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf
11/24/2004 SUPPL-35 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf
11/04/2004 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf
09/14/2004 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf
09/14/2004 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf
07/14/2004 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s030,20635s030lbl.pdf
03/05/2004 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf
05/23/2003 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf
12/18/2001 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
12/18/2001 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
12/18/2001 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
09/08/2000 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
09/08/2000 SUPPL-12 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
12/17/1998 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf

LEVAQUIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVAQUIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription Yes AB 020634 JANSSEN PHARMS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 203613 JUBILANT GENERICS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
LEVOFLOXACIN LEVOFLOXACIN 250MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVAQUIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription Yes AB 020634 JANSSEN PHARMS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 203613 JUBILANT GENERICS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
LEVOFLOXACIN LEVOFLOXACIN 500MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

TABLET;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVAQUIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription Yes AB 020634 JANSSEN PHARMS
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090787 APOTEX INC
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 201043 AUROBINDO PHARMA LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076890 CIPLA LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076710 DR REDDYS LABS INC
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 200250 GLENMARK GENERICS
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 202801 HETERO LABS LTD V
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 078424 LUPIN
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 200839 MACLEODS PHARMS LTD
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 202200 ORCHID HLTHCARE
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 077438 SANDOZ
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 076361 TEVA
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090722 TORRENT PHARMS
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 090367 WOCKHARDT
LEVOFLOXACIN LEVOFLOXACIN 750MG TABLET;ORAL Prescription No AB 077652 ZYDUS PHARMS USA INC

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