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FDA Drug Application 021588 by NOVARTIS

Application Number	021588
Application Type	New Drug Application
Sponsor Applicant	NOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential
Orphan Code

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

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