Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 12/20/1996 | N | 16285 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020634_levaquin_toc.cfm
| 4/24/2007 |
AP | 0 | 12/20/1996 | N | 24003 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
| 11/19/2009 |
AP | 0 | 1/30/1998 | SCS | | | |
| |
AP | 0 | 5/11/1998 | SCM | | | |
| |
AP | 0 | 3/24/1998 | SCM | | | |
| |
AP | 0 | 12/17/1998 | SE1 | 916 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04.cfm
| 7/2/1999 |
AP | 0 | 12/17/1998 | SE1 | 4787 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_appltr.pdf
| 12/17/1998 |
AP | 0 | 12/17/1998 | SE1 | 9164 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P1.pdf
| 6/8/2004 |
AP | 0 | 12/17/1998 | SE1 | 9165 | 004 | Label Pt. 2 |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020634s04_prntlbl_P2.pdf
| 6/8/2004 |
AP | 0 | 7/29/1999 | SLR | | | |
| |
AP | 0 | 7/29/1999 | SLR | | | |
| |
AP | 0 | 7/29/1999 | SLR | | | |
| |
AP | 0 | 2/2/2000 | SE1 | 1260 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF
| 2/2/2000 |
AP | 0 | 2/2/2000 | SE1 | 10153 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm
| 9/9/2004 |
AP | 0 | 2/2/2000 | SLR | 1265 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S7,8LTR.PDF
| 2/2/2000 |
AP | 0 | 2/2/2000 | SLR | 10154 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-634s008s009_20-635s007s008_Levaquin.cfm
| 9/9/2004 |
AP | 0 | 9/29/1999 | SCS | | | |
| |
AP | 0 | 2/11/2000 | SCS | | | |
| |
AP | 0 | 9/8/2000 | SCS | 1459 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf
| 9/8/2000 |
AP | 0 | 9/8/2000 | SCS | 1460 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
| 9/8/2000 |
AP | 0 | 9/8/2000 | SE1 | 1468 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20635S10ltr.pdf
| 9/8/2000 |
AP | 0 | 9/8/2000 | SE1 | 1469 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20634S13lbl.pdf
| 9/8/2000 |
AP | 0 | 8/28/2000 | SCM | | | |
| |
AP | 0 | 12/18/2001 | SLR | 2806 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 2807 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 11895 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
| 6/27/2005 |
AP | 0 | 12/13/2000 | SCP | | | |
| |
AP | 0 | 9/15/2000 | SCS | | | |
| |
AP | 0 | 1/4/2001 | SCM | | | |
| |
AP | 0 | 2/13/2001 | SCS | | | |
| |
AP | 0 | 6/8/2001 | SCM | | | |
| |
AP | 0 | 12/18/2001 | SLR | 2849 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 2850 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 11896 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
| 6/27/2005 |
AP | 0 | 12/18/2001 | SLR | 2851 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20634s15s21s22ltr.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 2852 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20634s15s21s22lbl.pdf
| 12/18/2001 |
AP | 0 | 12/18/2001 | SLR | 11897 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-634s015s021s022_020635s012s019s020_LevaquinTOC.cfm
| 6/27/2005 |
AP | 0 | 1/11/2002 | SCS | | | |
| |
AP | 0 | 4/30/2002 | SCS | | | |
| |
AP | 0 | 10/30/2002 | SE1 | 3080 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20634se1-025,20635se1-022ltr.pdf
| 10/30/2002 |
AP | 0 | 6/12/2002 | SCS | | | |
| |
AP | 0 | 5/23/2003 | SE1 | 5820 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se1-027,20635se1-026ltr.pdf
| 6/8/2003 |
AP | 0 | 5/23/2003 | SE1 | 5884 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20634se1-027,20635se1-026_levaquin_lbl.pdf
| 6/8/2003 |
AP | 0 | 5/23/2003 | SE1 | 20403 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S027_LEVAQUIN.pdf
| 8/1/2008 |
AP | 0 | 10/23/2003 | SE2 | 7049 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20634se2-028,20635se2-027ltr.pdf
| 12/4/2003 |
AP | 0 | 10/23/2003 | SE2 | 20404 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020634_S028_LEVAQUIN.pdf
| 8/1/2008 |
AP | 0 | 3/5/2004 | SLR | 7854 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634slr029,20635slr029ltr.pdf
| 3/10/2004 |
AP | 0 | 3/5/2004 | SLR | 8249 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634slr029,20635slr029_levaquin_lbl.pdf
| 4/5/2004 |
AP | 0 | 7/14/2004 | SE1 | 9774 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s030,20635s030lbl.pdf
| 7/21/2004 |
AP | 0 | 9/14/2004 | SLR | 10207 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf
| 9/15/2004 |
AP | 0 | 9/14/2004 | SLR | 10213 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf
| 9/15/2004 |
AP | 0 | 9/14/2004 | SLR | 23448 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S033_Levaquin.pdf
| 9/17/2009 |
AP | 0 | 9/14/2004 | SLR | 10206 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf
| 9/15/2004 |
AP | 0 | 9/14/2004 | SLR | 10212 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s033,034,20635s033,034lbl.pdf
| 9/15/2004 |
AP | 0 | 9/14/2004 | SLR | 23449 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020634_S034_Levaquin.pdf
| 9/17/2009 |
AP | 0 | 11/24/2004 | SE1 | 10685 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf
| 12/2/2004 |
AP | 0 | 11/24/2004 | SE1 | 10708 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf
| 12/3/2004 |
AP | 0 | 11/4/2004 | SLR | 10546 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf
| 11/8/2004 |
AP | 0 | 11/4/2004 | SLR | 10560 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20635s037,20634s036lbl.pdf
| 11/8/2004 |
AP | 0 | 8/4/2005 | SE2 | 12550 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf
| 8/8/2005 |
AP | 0 | 8/4/2005 | SE2 | 12566 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf
| 8/8/2005 |
AP | 0 | 1/20/2006 | SLR | 13507 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf
| 1/27/2006 |
AP | 0 | 6/23/2006 | SLR | 14355 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf
| 6/28/2006 |
AP | 0 | 6/23/2006 | SLR | 14379 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf
| 6/28/2006 |
AP | 0 | 9/14/2007 | SE2 | 17898 | 041 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf
| 9/19/2007 |
AP | 0 | 9/14/2007 | SE2 | 17960 | 041 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf
| 9/25/2007 |
AP | 0 | 5/31/2007 | SLR | 16675 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf
| 6/4/2007 |
AP | 0 | 5/31/2007 | SLR | 16692 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf
| 6/4/2007 |
AP | 0 | 9/11/2007 | SE5 | 17912 | 043 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf
| 9/19/2007 |
AP | 0 | 9/11/2007 | SE5 | 17964 | 043 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf
| 9/25/2007 |
AP | 0 | 5/10/2007 | SLR | 16570 | 044 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf
| 5/16/2007 |
AP | 0 | 5/10/2007 | SLR | 16577 | 044 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf
| 5/16/2007 |
AP | 0 | 6/19/2007 | SLR | 16836 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf
| 6/27/2007 |
AP | 0 | 6/19/2007 | SLR | 16911 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf
| 7/5/2007 |
AP | 0 | 5/5/2008 | SE5 | 19786 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf
| 5/8/2008 |
AP | 0 | 5/5/2008 | SE5 | 20220 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020634se5-047,020635se5-051,021721se5-015_SUMR.pdf
| 7/16/2008 |
AP | 0 | 11/15/2007 | SLR | 18429 | 048 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf
| 11/19/2007 |
AP | 0 | 11/15/2007 | SLR | 18468 | 048 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf
| 11/19/2007 |
AP | 0 | 11/16/2007 | SLR | 18434 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf
| 11/19/2007 |
AP | 0 | 11/16/2007 | SLR | 18469 | 049 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf
| 11/19/2007 |
AP | 0 | 12/13/2007 | SLR | 18652 | 050 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf
| 12/14/2007 |
AP | 0 | 12/13/2007 | SLR | 18840 | 050 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf
| 1/9/2008 |
AP | 0 | 4/16/2008 | SLR | 19676 | 051 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf
| 4/18/2008 |
AP | 0 | 4/16/2008 | SLR | 19932 | 051 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf
| 6/5/2008 |
AP | 0 | 10/3/2008 | SLR | 20964 | 052 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf
| 10/7/2008 |
AP | 0 | 10/3/2008 | SLR | 20978 | 052 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf
| 10/8/2008 |
AP | 0 | 4/27/2009 | SLR | 22419 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf
| 5/5/2009 |
AP | 0 | 4/27/2009 | SLR | 22502 | 053 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf
| 5/11/2009 |
AP | 0 | 3/12/2009 | SLR | 21993 | 054 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf
| 3/13/2009 |
AP | 0 | 2/25/2011 | SLR | 28024 | 058 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf
| 3/3/2011 |
AP | 0 | 2/25/2011 | SLR | 28069 | 058 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf
| 3/4/2011 |
AP | 0 | 6/9/2011 | SLR | 29134 | 059 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf
| 6/14/2011 |
AP | 0 | 6/9/2011 | SLR | 29137 | 059 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf
| 6/14/2011 |
AP | 0 | 4/27/2012 | SE8 | 32562 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf
| 4/30/2012 |
AP | 0 | 4/27/2012 | SE8 | 32563 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028mg.pdf
| 4/30/2012 |
AP | 0 | 4/27/2012 | SE8 | 32564 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf
| 5/1/2012 |
AP | 0 | 4/27/2012 | SE8 | 42097 | 061 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm
| 3/11/2015 |
AP | 0 | 10/11/2011 | SLR | 30290 | 062 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
| 10/12/2011 |
AP | 0 | 10/11/2011 | SLR | 30319 | 062 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf
| 10/13/2011 |
AP | 0 | 10/11/2011 | SLR | 32978 | 062 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf
| 6/22/2012 |
AP | 0 | 10/11/2011 | SLR | 30291 | 064 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
| 10/12/2011 |
AP | 0 | 10/11/2011 | SLR | 30320 | 064 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s062,s064,020635s068,s070,021721s029,s031ltr.pdf
| 10/13/2011 |
AP | 0 | 10/11/2011 | SLR | 32979 | 064 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020634Orig1s062s064.pdf
| 6/22/2012 |
AP | 0 | 8/14/2013 | SLR | 36801 | 065 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf
| 8/15/2013 |
AP | 0 | 8/14/2013 | SLR | 36818 | 065 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf
| 8/16/2013 |
AP | 0 | 5/23/2014 | SLR | 39366 | 066 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf
| 5/28/2014 |
AP | 0 | 5/23/2014 | SLR | 39373 | 066 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf
| 5/28/2014 |
AP | 0 | 7/26/2016 | SLR | 46621 | 067 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf
| 7/26/2016 |
AP | 0 | 7/26/2016 | SLR | 46630 | 067 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf
| 7/26/2016 |