Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 5/17/2007 | N | 24872 | 000 | |
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM194582.pdf
| 2/26/2010 |
AP | 0 | 5/17/2007 | N | 30097 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022047s000TOC.cfm
| 9/27/2011 |
AP | 0 | 5/17/2007 | N | 30100 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022047Orig1s000ltr.pdf
| 9/28/2011 |
AP | 0 | 5/17/2007 | N | 31198 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm
| 12/22/2011 |
AP | 0 | 3/13/2008 | SCM | 19470 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s002ltr.pdf
| 3/17/2008 |
AP | 0 | 3/13/2008 | SCM | 19477 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s002lbl.pdf
| 3/17/2008 |
AP | 0 | 10/8/2008 | SE1 | 20984 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf
| 10/9/2008 |
AP | 0 | 10/8/2008 | SE1 | 21191 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf
| 11/7/2008 |
AP | 0 | 10/8/2008 | SE1 | 47055 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm
| 9/15/2016 |
AP | 0 | 10/8/2008 | SE1 | 20985 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf
| 10/9/2008 |
AP | 0 | 10/8/2008 | SE1 | 21192 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf
| 11/7/2008 |
AP | 0 | 10/8/2008 | SE1 | 47056 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm
| 9/15/2016 |
AP | 0 | 10/8/2008 | SE1 | 20983 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s006, s007, s008ltr.pdf
| 10/9/2008 |
AP | 0 | 10/8/2008 | SE1 | 21193 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s006s007s008lbl.pdf
| 11/7/2008 |
AP | 0 | 10/8/2008 | SE1 | 47057 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008TOC.cfm
| 9/15/2016 |
AP | 0 | 5/21/2008 | SLR | 19886 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s009ltr.pdf
| 5/28/2008 |
AP | 0 | 12/2/2009 | SE1 | 24255 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SE1 | 24260 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SE1 | 24360 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf
| 12/30/2009 |
AP | 0 | 12/2/2009 | SE1 | 40103 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022047Orig1s011.pdf
| 8/1/2014 |
AP | 0 | 8/11/2008 | SCM | 20607 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s013ltr.pdf
| 8/13/2008 |
AP | 0 | 8/11/2008 | SCM | 20712 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022047s013lbl.pdf
| 8/29/2008 |
AP | 0 | 12/2/2009 | SLR | 24256 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24261 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24361 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf
| 12/30/2009 |
AP | 0 | 12/2/2009 | SLR | 24257 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24262 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24362 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf
| 12/30/2009 |
AP | 0 | 8/14/2008 | SLR | 20632 | 018 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022047s018ltr.pdf
| 8/19/2008 |
AP | 0 | 12/2/2009 | SLR | 24258 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24263 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022MedGuide.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24363 | 019 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf
| 12/30/2009 |
AP | 0 | 12/2/2009 | SLR | 24259 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022047s011s016s017s019s022lbl.pdf
| 12/11/2009 |
AP | 0 | 12/2/2009 | SLR | 24364 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022047s011s016s017s019s022ltr.pdf
| 12/30/2009 |
AP | 0 | 7/8/2011 | SLR | 29484 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29495 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf
| 7/12/2011 |
AP | 0 | 5/17/2011 | SLR | 28861 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s024ltr.pdf
| 5/19/2011 |
AP | 0 | 5/17/2011 | SLR | 28903 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s024lbl.pdf
| 5/23/2011 |
AP | 0 | 12/1/2010 | SLR | 27184 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022047s025lbl.pdf
| 12/4/2010 |
AP | 0 | 12/1/2010 | SLR | 27245 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022047s025ltr.pdf
| 12/7/2010 |
AP | 0 | 4/30/2013 | SLR | 35907 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35929 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 7/8/2011 | SLR | 29485 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s023,s027ltr.pdf
| 7/12/2011 |
AP | 0 | 7/8/2011 | SLR | 29496 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s023s027lbl.pdf
| 7/12/2011 |
AP | 0 | 11/9/2011 | SLR | 30555 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022047s028MG.pdf
| 11/10/2011 |
AP | 0 | 11/9/2011 | SLR | 30567 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022047s028ltr.pdf
| 11/14/2011 |
AP | 0 | 4/30/2013 | SE8 | 35908 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SE8 | 35930 | 029 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 4/30/2013 | SLR | 35909 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35931 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 4/30/2013 | SLR | 35910 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s026s029s030s031lbl.pdf
| 5/1/2013 |
AP | 0 | 4/30/2013 | SLR | 35932 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s053,s057,s058,s059;022047s026,029,s030,s031ltr.pdf
| 5/2/2013 |
AP | 0 | 10/29/2013 | SLR | 37616 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020639Orig1s061,022047Orig1s034ltr.pdf
| 10/30/2013 |
AP | 0 | 10/29/2013 | SLR | 37644 | 034 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022047s034lbl.pdf
| 10/31/2013 |
AP | 0 | 1/26/2015 | SCM | 46131 | 036 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022047s036lbl.pdf
| 5/25/2016 |
AP | 0 | 6/17/2016 | SLR | 46361 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020639Orig1s064,022047Orig1s038ltr.pdf
| 6/21/2016 |
AP | 0 | 6/17/2016 | SLR | 46383 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022047s038lbl.pdf
| 6/21/2016 |