Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 10/28/2005 | N | 12995 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021906lbl.pdf
| 11/1/2005 |
AP | 0 | 10/28/2005 | N | 13005 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021906ltr.pdf
| 11/1/2005 |
AP | 0 | 10/28/2005 | N | 17296 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021906s000TOC.cfm
| 7/18/2007 |
AP | 0 | 10/28/2005 | N | 24001 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM310187.pdf
| 11/19/2009 |
AP | 0 | 4/20/2007 | SE8 | 16300 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf
| 4/25/2007 |
AP | 0 | 4/20/2007 | SE8 | 16308 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf
| 4/25/2007 |
AP | 0 | 12/21/2006 | SLR | 15515 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf
| 12/28/2006 |
AP | 0 | 12/21/2006 | SLR | 15589 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf
| 1/8/2007 |
AP | 0 | 3/2/2007 | SLR | 15969 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf
| 3/7/2007 |
AP | 0 | 3/2/2007 | SLR | 15985 | 004 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf
| 3/7/2007 |
AP | 0 | 6/29/2007 | SLR | 16877 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf
| 7/5/2007 |
AP | 0 | 6/29/2007 | SLR | 16950 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf
| 7/5/2007 |
AP | 0 | 11/9/2007 | SE2 | 18421 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf
| 11/19/2007 |
AP | 0 | 11/9/2007 | SE2 | 18459 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf
| 11/19/2007 |
AP | 0 | 9/25/2007 | SLR | 18034 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf
| 9/26/2007 |
AP | 0 | 9/25/2007 | SLR | 18151 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf
| 10/4/2007 |
AP | 0 | 6/20/2008 | SLR | 20067 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf
| 6/24/2008 |
AP | 0 | 6/20/2008 | SLR | 20084 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf
| 6/26/2008 |
AP | 0 | 4/6/2009 | SLR | 22228 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf
| 4/10/2009 |
AP | 0 | 4/6/2009 | SLR | 22273 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf
| 4/16/2009 |
AP | 0 | 10/3/2008 | SLR | 20973 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf
| 10/8/2008 |
AP | 0 | 10/3/2008 | SLR | 21009 | 015 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf
| 10/9/2008 |
AP | 0 | 4/20/2009 | SE8 | 22312 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf
| 4/23/2009 |
AP | 0 | 4/20/2009 | SE8 | 22319 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf
| 4/24/2009 |
AP | 0 | 1/29/2010 | SLR | 24703 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf
| 2/4/2010 |
AP | 0 | 1/29/2010 | SLR | 24740 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf
| 2/5/2010 |
AP | 0 | 4/27/2010 | SE5 | 25446 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf
| 5/3/2010 |
AP | 0 | 4/27/2010 | SE5 | 25511 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf
| 5/7/2010 |
AP | 0 | 6/14/2010 | SLR | 25741 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s026lbl.pdf
| 6/15/2010 |
AP | 0 | 6/14/2010 | SLR | 25750 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf
| 6/16/2010 |
AP | 0 | 2/24/2011 | SLR | 27990 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf
| 3/1/2011 |
AP | 0 | 2/24/2011 | SLR | 28048 | 032 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf
| 3/4/2011 |
AP | 0 | 5/6/2011 | SLR | 28778 | 033 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf
| 5/10/2011 |
AP | 0 | 4/20/2012 | SLR | 32511 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf
| 4/24/2012 |
AP | 0 | 4/20/2012 | SLR | 32512 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034mg.pdf
| 4/24/2012 |
AP | 0 | 4/20/2012 | SLR | 32528 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf
| 4/24/2012 |
AP | 0 | 2/17/2012 | SLR | 31857 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf
| 2/22/2012 |
AP | 0 | 2/17/2012 | SLR | 31895 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf
| 2/27/2012 |
AP | 0 | 5/16/2012 | SLR | 32701 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf
| 5/17/2012 |
AP | 0 | 5/16/2012 | SLR | 32702 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044mg.pdf
| 5/17/2012 |
AP | 0 | 5/16/2012 | SLR | 32712 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf
| 5/18/2012 |
AP | 0 | 11/30/2012 | SCM | | | |
| |
AP | 0 | 1/17/2013 | SLR | 34901 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf
| 1/22/2013 |
AP | 0 | 1/17/2013 | SLR | 34924 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf
| 1/22/2013 |
AP | 0 | 11/7/2013 | SLR | 37765 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf
| 11/8/2013 |
AP | 0 | 11/7/2013 | SLR | 37779 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf
| 11/8/2013 |
AP | 0 | 1/28/2015 | SE8 | 41716 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf
| 1/29/2015 |
AP | 0 | 1/28/2015 | SE8 | 41744 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf
| 1/30/2015 |
AP | 0 | 6/26/2015 | SE8 | 43177 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf
| 7/1/2015 |
AP | 0 | 6/26/2015 | SE8 | 43249 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf
| 7/6/2015 |
AP | 0 | 3/27/2015 | SLR | 42346 | 043 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf
| 4/1/2015 |
AP | 0 | 3/27/2015 | SLR | 42403 | 043 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf
| 4/2/2015 |
AP | 0 | 11/10/2015 | SLR | 44457 | 044 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf
| 11/12/2015 |
AP | 0 | 11/10/2015 | SLR | 44490 | 044 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf
| 11/17/2015 |
AP | 0 | 12/2/2015 | SCM | | | |
| |
AP | 0 | 9/15/2016 | SLR | 47081 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf
| 9/20/2016 |
AP | 0 | 9/15/2016 | SLR | 47123 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf
| 9/20/2016 |