Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 11/23/2005 | N | 13136 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021700lbl.pdf
| 11/30/2005 |
AP | 0 | 11/23/2005 | N | 13173 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021700ltr.pdf
| 11/30/2005 |
AP | 0 | 11/23/2005 | N | 16869 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021700s000TOC.cfm
| 7/2/2007 |
AP | 0 | 11/23/2005 | N | 19248 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm
| 2/21/2008 |
AP | 0 | 11/23/2005 | N | 23885 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143421.pdf
| 11/16/2009 |
AP | 0 | 6/15/2006 | SLR | 14326 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf
| 6/20/2006 |
AP | 0 | 6/15/2006 | SLR | 14330 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf
| 6/20/2006 |
AP | 0 | 10/24/2006 | SE1 | 15203 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s003lbl.pdf
| 10/25/2006 |
AP | 0 | 10/24/2006 | SE1 | 15250 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s003ltr.pdf
| 10/26/2006 |
AP | 0 | 6/15/2006 | SLR | 14327 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021700s002s004lbl.pdf
| 6/20/2006 |
AP | 0 | 6/15/2006 | SLR | 14331 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021700s002,217s004LTR.pdf
| 6/20/2006 |
AP | 0 | 3/30/2007 | SCM | 16175 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s005ltr.pdf
| 4/9/2007 |
AP | 0 | 9/20/2007 | SLR | 17977 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s006ltr.pdf
| 9/25/2007 |
AP | 0 | 8/21/2007 | SLR | 17670 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021700s007lbl.pdf
| 8/22/2007 |
AP | 0 | 8/21/2007 | SLR | 17680 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021700s007ltr.pdf
| 8/22/2007 |
AP | 0 | 12/2/2008 | SLR | 21320 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021700s008ltr.pdf
| 12/4/2008 |
AP | 0 | 12/2/2008 | SLR | 21326 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021700s008lbl.pdf
| 12/4/2008 |
AP | 0 | 11/29/2009 | SLR | 24242 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021700s009lbl.pdf
| 12/10/2009 |
AP | 0 | 2/3/2011 | SLR | 27685 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf
| 2/3/2011 |
AP | 0 | 2/3/2011 | SLR | 27703 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf
| 2/4/2011 |
AP | 0 | 5/18/2011 | SLR | 28853 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011lbl.pdf
| 5/17/2011 |
AP | 0 | 5/18/2011 | SLR | 28854 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s011MedG.pdf
| 5/17/2011 |
AP | 0 | 5/18/2011 | SLR | 28915 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf
| 5/24/2011 |
AP | 0 | 11/13/2011 | SLR | 30626 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012lbl.pdf
| 11/16/2011 |
AP | 0 | 11/13/2011 | SLR | 30627 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021700s012MedG.pdf
| 11/16/2011 |
AP | 0 | 11/13/2011 | SLR | 30693 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf
| 11/21/2011 |
AP | 0 | 5/30/2012 | SLR | 32788 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf
| 6/4/2012 |
AP | 0 | 5/30/2012 | SLR | 32829 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021700s013lbl.pdf
| 6/6/2012 |
AP | 0 | 1/25/2013 | S | 35004 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf
| 1/30/2013 |
AP | 0 | 9/16/2013 | SLR | 37156 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf
| 9/19/2013 |
AP | 0 | 5/7/2014 | SLR | 39247 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
| 5/8/2014 |
AP | 0 | 5/7/2014 | SLR | 39279 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
| 5/12/2014 |
AP | 0 | 5/7/2014 | SLR | 39248 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
| 5/8/2014 |
AP | 0 | 5/7/2014 | SLR | 39280 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
| 5/12/2014 |
AP | 0 | 5/7/2014 | SLR | 39249 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021700Orig1s018,s019,s020ltr.pdf
| 5/8/2014 |
AP | 0 | 5/7/2014 | SLR | 39281 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021700s018s019s020lbl.pdf
| 5/12/2014 |
AP | 0 | 3/16/2015 | SLR | 42168 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021700Orig1s021ltr.pdf
| 3/17/2015 |
AP | 0 | 3/16/2015 | SLR | 42198 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021700s021lbl.pdf
| 3/19/2015 |
AP | 0 | 12/16/2015 | S | 44794 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf
| 12/17/2015 |