Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 10/21/2004 | N | 10502 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21721ltr.pdf
| 10/29/2004 |
AP | 0 | 10/21/2004 | N | 10524 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21721lbl.pdf
| 11/1/2004 |
AP | 0 | 10/21/2004 | N | 16284 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021721s000TOC.cfm
| 4/20/2007 |
AP | 0 | 10/21/2004 | N | 24005 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088619.pdf
| 11/19/2009 |
AP | 0 | 8/4/2005 | SE2 | 12548 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020634s037,020635s038,021721s002ltr.pdf
| 8/8/2005 |
AP | 0 | 8/4/2005 | SE2 | 12564 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020634s037,020635s038,021721s002lbl.pdf
| 8/8/2005 |
AP | 0 | 11/24/2004 | SE1 | 10687 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf
| 12/2/2004 |
AP | 0 | 11/24/2004 | SE1 | 10710 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20634s035,20635s035,21721s003lbl.pdf
| 12/3/2004 |
AP | 0 | 1/20/2006 | SLR | 13509 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s039,020635s042,021721s006lbl.pdf
| 1/27/2006 |
AP | 0 | 1/20/2006 | SLR | 13557 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021721s006ltr.pdf
| 1/30/2006 |
AP | 0 | 6/23/2006 | SLR | 14357 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020634s040,020635s043,021721s007LTR.pdf
| 6/28/2006 |
AP | 0 | 6/23/2006 | SLR | 14377 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020634s040,020635s043,021721s007lbl.pdf
| 6/28/2006 |
AP | 0 | 9/14/2007 | SE2 | 17896 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s041,020635s044,021721s009lbl.pdf
| 9/19/2007 |
AP | 0 | 9/14/2007 | SE2 | 17962 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s041,020635s044,021721s009ltr.pdf
| 9/25/2007 |
AP | 0 | 5/31/2007 | SLR | 16673 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf
| 6/4/2007 |
AP | 0 | 5/31/2007 | SLR | 16690 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s042,020635s045,021721s010lbl.pdf
| 6/4/2007 |
AP | 0 | 9/11/2007 | SE5 | 17910 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s043,020635s046,021721s011lbl.pdf
| 9/19/2007 |
AP | 0 | 9/11/2007 | SE5 | 17963 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s043,020635s046,021721s011ltr.pdf
| 9/25/2007 |
AP | 0 | 5/10/2007 | SLR | 16568 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf
| 5/16/2007 |
AP | 0 | 5/10/2007 | SLR | 16575 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s044,020635s047,021721s012lbl.pdf
| 5/16/2007 |
AP | 0 | 6/19/2007 | SLR | 16838 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s045,020635s048,021721s031lbl.pdf
| 6/27/2007 |
AP | 0 | 6/19/2007 | SLR | 16909 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf
| 7/5/2007 |
AP | 0 | 5/5/2008 | SE5 | 19788 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634se5-047020635se5-051021721se5-015ltr.pdf
| 5/8/2008 |
AP | 0 | 5/5/2008 | SE5 | 20218 | 015 | |
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 | 18427 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s048,020635s052,021721s016lbl.pdf
| 11/19/2007 |
AP | 0 | 11/15/2007 | SLR | 18466 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf
| 11/19/2007 |
AP | 0 | 11/16/2007 | SLR | 18432 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s049,020635s053,021721s017lbl.pdf
| 11/19/2007 |
AP | 0 | 11/16/2007 | SLR | 18471 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s049,020635s053,021721s017ltr.pdf
| 11/19/2007 |
AP | 0 | 12/13/2007 | SLR | 18650 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020634s050,020635s054,021721s018lbl.pdf
| 12/14/2007 |
AP | 0 | 12/13/2007 | SLR | 18838 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s050, 020635s054, 021721s018ltr.pdf
| 1/9/2008 |
AP | 0 | 4/16/2008 | SLR | 19678 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s051, 020635s055, 021721s019ltr.pdf
| 4/18/2008 |
AP | 0 | 4/16/2008 | SLR | 19930 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020634s051,020635s055,021721s019lbl.pdf
| 6/5/2008 |
AP | 0 | 10/3/2008 | SLR | 20966 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020634s052, 020635s057,021721s020ltr .pdf
| 10/7/2008 |
AP | 0 | 10/3/2008 | SLR | 20976 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021721s020_020635s57_020634s52_lbl.pdf
| 10/8/2008 |
AP | 0 | 4/27/2009 | SLR | 22421 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s053,020635s058,021721s021lt.pdf
| 5/5/2009 |
AP | 0 | 4/27/2009 | SLR | 22500 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020634s053,020635s058, 021721s021lbl.pdf
| 5/11/2009 |
AP | 0 | 3/12/2009 | SLR | 21995 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020634s054,020635s059,021721s022ltr.pdf
| 3/13/2009 |
AP | 0 | 2/25/2011 | SLR | 28026 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s058,020635s064,021721s025ltr.pdf
| 3/3/2011 |
AP | 0 | 2/25/2011 | SLR | 28067 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s058,020635s064,021721s025lbl.pdf
| 3/4/2011 |
AP | 0 | 6/9/2011 | SLR | 29132 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s059,020635s065,021721s026lbl.pdf
| 6/14/2011 |
AP | 0 | 6/9/2011 | SLR | 29139 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020634s059,020635s065,021721s026ltr.pdf
| 6/14/2011 |
AP | 0 | 4/27/2012 | SE8 | 32558 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028lbl.pdf
| 4/30/2012 |
AP | 0 | 4/27/2012 | SE8 | 32559 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020634s061,020635s067,021721s028mg.pdf
| 4/30/2012 |
AP | 0 | 4/27/2012 | SE8 | 32566 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020634s061,020635s067,021721s028ltr.pdf
| 5/1/2012 |
AP | 0 | 4/27/2012 | SE8 | 42067 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061, 020635Orig1s067, 021721Orig1s028TOC.cfm
| 3/10/2015 |
AP | 0 | 4/27/2012 | SE8 | 42068 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020634Orig1s061,%20020635Orig1s067,%20021721Orig1s028SumR.pdf
| 3/10/2015 |
AP | 0 | 10/11/2011 | SLR | 30294 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
| 10/12/2011 |
AP | 0 | 10/11/2011 | SLR | 30323 | 029 | |
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 | 32974 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf
| 6/22/2012 |
AP | 0 | 10/11/2011 | SLR | 30295 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020634s062s064,020635s068s070,021721s029s031lbl.pdf
| 10/12/2011 |
AP | 0 | 10/11/2011 | SLR | 30324 | 031 | |
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 | 32975 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021721Orig1s029s031.pdf
| 6/22/2012 |
AP | 0 | 8/14/2013 | SLR | 36799 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020634s065,020635s071,021721s032lbl.pdf
| 8/15/2013 |
AP | 0 | 8/14/2013 | SLR | 36820 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020634Orig1s065,020635Orig1s071,021721Orig1s032ltr_replace.pdf
| 8/16/2013 |
AP | 0 | 5/23/2014 | SLR | 39368 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020634Orig1s066,020635Orig1s072,021721Orig1s033ltr.pdf
| 5/28/2014 |
AP | 0 | 5/23/2014 | SLR | 39371 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020634s066,020635s072,021721s033lbl.pdf
| 5/28/2014 |
AP | 0 | 7/26/2016 | SLR | 46623 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020634s067,020635s073,021721s034lbl.pdf
| 7/26/2016 |
AP | 0 | 7/26/2016 | SLR | 46632 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020634s067_020635s073_021721Orig1s034ltr.pdf
| 7/26/2016 |