Action Type | Duplicate Counter | Action Date | Document Type | Application Document ID | Sequence Number | Document Title | Document URL | Document Date |
AP | 0 | 4/18/2003 | N | 5499 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf
| 4/28/2003 |
AP | 0 | 4/18/2003 | N | 5713 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588ltr.pdf
| 5/29/2003 |
AP | 0 | 4/18/2003 | N | 7122 | 000 | |
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110502.htm
| 12/9/2003 |
AP | 0 | 4/18/2003 | N | 14246 | 000 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021588s000_GleevecTOC.cfm
| 6/7/2006 |
AP | 0 | 5/20/2003 | SE5 | 5645 | 001 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf
| 5/20/2003 |
AP | 0 | 5/20/2003 | SE5 | 5841 | 001 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf
| 6/8/2003 |
AP | 0 | 5/20/2003 | SE5 | 9958 | 001 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm
| 8/9/2004 |
AP | 0 | 12/8/2003 | SE7 | 7061 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf
| 12/8/2003 |
AP | 0 | 12/8/2003 | SE7 | 7301 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se7-002ltr.pdf
| 12/22/2003 |
AP | 0 | 12/8/2003 | SE7 | 11359 | 002 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-588s002_Gleevec.cfm
| 4/8/2005 |
AP | 0 | 6/23/2004 | SLR | 9543 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21588slr003ltr.pdf
| 6/25/2004 |
AP | 0 | 6/23/2004 | SLR | 9566 | 003 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf
| 6/25/2004 |
AP | 0 | 3/14/2005 | SE8 | 11255 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf
| 3/18/2005 |
AP | 0 | 3/14/2005 | SE8 | 11276 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf
| 3/18/2005 |
AP | 0 | 3/14/2005 | SE8 | 42894 | 005 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf
| 5/26/2015 |
AP | 0 | 5/19/2005 | SCS | 11674 | 006 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf
| 5/20/2005 |
AP | 0 | 5/18/2005 | SLR | 11675 | 007 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s007ltr.pdf
| 5/20/2005 |
AP | 0 | 10/20/2005 | SE8 | 12959 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf
| 10/25/2005 |
AP | 0 | 10/20/2005 | SE8 | 12962 | 008 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s008ltr.pdf
| 10/25/2005 |
AP | 0 | 10/30/2006 | SLR | 15299 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf
| 11/6/2006 |
AP | 0 | 10/30/2006 | SLR | 15315 | 009 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s009ltr.pdf
| 11/6/2006 |
AP | 0 | 5/31/2006 | SLR | 14196 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf
| 6/1/2006 |
AP | 0 | 5/31/2006 | SLR | 14215 | 010 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s008, s010LTR.pdf
| 6/2/2006 |
AP | 0 | 10/19/2006 | SE1 | 15145 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 15169 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 27035 | 011 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf
| 10/19/2006 |
AP | 0 | 10/19/2006 | SE1 | 15146 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 15170 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 27036 | 012 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s012_gleevic.pdf
| 10/19/2006 |
AP | 0 | 10/19/2006 | SE1 | 15147 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 15171 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 27037 | 013 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s013_gleevic.pdf
| 10/19/2006 |
AP | 0 | 10/19/2006 | SE1 | 15148 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 15172 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 27038 | 014 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s014_gleevec.pdf
| 10/19/2006 |
AP | 0 | 9/27/2006 | SE1 | 15024 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf
| 9/28/2006 |
AP | 0 | 9/27/2006 | SE1 | 15043 | 016 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf
| 10/2/2006 |
AP | 0 | 10/19/2006 | SE1 | 15149 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 15173 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf
| 10/23/2006 |
AP | 0 | 10/19/2006 | SE1 | 27039 | 017 | |
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf
| 10/19/2006 |
AP | 0 | 9/13/2007 | SE8 | 17905 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf
| 9/19/2007 |
AP | 0 | 9/13/2007 | SE8 | 17975 | 020 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf
| 9/25/2007 |
AP | 0 | 9/26/2008 | SLR | 20909 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s021ltr.pdf
| 10/1/2008 |
AP | 0 | 9/26/2008 | SLR | 20922 | 021 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
| 9/26/2008 |
AP | 0 | 9/26/2008 | SLR | 20910 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf
| 10/1/2008 |
AP | 0 | 9/26/2008 | SLR | 20923 | 022 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
| 9/26/2008 |
AP | 0 | 4/30/2008 | SCP | 19765 | 023 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s023ltr.pdf
| 5/5/2008 |
AP | 0 | 9/26/2008 | SE7 | 20895 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf
| 9/26/2008 |
AP | 0 | 9/26/2008 | SE7 | 20911 | 024 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf
| 10/1/2008 |
AP | 0 | 12/19/2008 | SLR | 21417 | 025 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s025ltr.pdf
| 12/29/2008 |
AP | 0 | 5/27/2009 | SE7 | 22672 | 026 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf
| 6/2/2009 |
AP | 0 | 2/10/2009 | SLR | 21817 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf
| 2/12/2009 |
AP | 0 | 2/10/2009 | SLR | 21823 | 027 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf
| 2/13/2009 |
AP | 0 | 5/27/2009 | SLR | 22673 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf
| 6/2/2009 |
AP | 0 | 5/27/2009 | SLR | 22700 | 028 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf
| 6/5/2009 |
AP | 0 | 4/1/2011 | SE7 | 28437 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf
| 4/1/2011 |
AP | 0 | 4/1/2011 | SE7 | 28467 | 030 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf
| 4/6/2011 |
AP | 0 | 4/1/2011 | SLR | 28438 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf
| 4/1/2011 |
AP | 0 | 4/1/2011 | SLR | 28468 | 031 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf
| 4/6/2011 |
AP | 0 | 1/31/2012 | SE7 | 31591 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf
| 1/31/2012 |
AP | 0 | 1/31/2012 | SE7 | 31640 | 035 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021588s035ltr_cor.pdf
| 2/3/2012 |
AP | 0 | 1/25/2013 | SE1 | 35005 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s037ltr.pdf
| 1/30/2013 |
AP | 0 | 1/25/2013 | SE1 | 35014 | 037 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf
| 1/30/2013 |
AP | 0 | 2/21/2013 | SLR | 35229 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s038ltr.pdf
| 2/25/2013 |
AP | 0 | 2/21/2013 | SLR | 35259 | 038 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf
| 2/26/2013 |
AP | 0 | 10/30/2013 | SLR | 37622 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s039ltr.pdf
| 10/31/2013 |
AP | 0 | 10/30/2013 | SLR | 37639 | 039 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf
| 10/31/2013 |
AP | 0 | 5/22/2014 | SLR | 39342 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021588Orig1s040ltr.pdf
| 5/22/2014 |
AP | 0 | 5/22/2014 | SLR | 39379 | 040 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf
| 5/28/2014 |
AP | 0 | 1/30/2015 | SE8 | 41755 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf
| 2/2/2015 |
AP | 0 | 1/30/2015 | SE8 | 41772 | 042 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf
| 2/3/2015 |
AP | 0 | 8/25/2016 | SE8 | 46895 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf
| 8/29/2016 |
AP | 0 | 8/25/2016 | SE8 | 46906 | 045 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf
| 8/29/2016 |
AP | 0 | 8/25/2016 | SLR | 46896 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf
| 8/29/2016 |
AP | 0 | 8/25/2016 | SLR | 46907 | 046 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf
| 8/29/2016 |
AP | 0 | 9/27/2016 | SLR | 47212 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf
| 9/29/2016 |
AP | 0 | 9/27/2016 | SLR | 47276 | 047 | |
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s047ltr.pdf
| 10/4/2016 |