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FDA Drug Application 018612 by GLAXOSMITHKLINE

Application Number	018612
Application Type	New Drug Application
Sponsor Applicant	GLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/13/1984	N
AP	2/21/1984	SLR
AP	3/2/1984	SLR
AP	9/12/1988	SLR
AP	2/26/1986	SCM
AP	7/23/1985	SCP
AP	2/26/1986	SCS
AP	9/12/1988	SLR
AP	7/23/1985	SLR
AP	4/17/1989	SCM
AP	9/28/1989	SCM
AP	9/30/1988	SCS
AP	8/22/1991	SCS
AP	8/22/1991	SCS
AP	2/9/1996	SE6	11562	022	http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018612s022_020066s004_Nicorette.cfm	5/2/2005
AP	11/4/1998	SCS
AP	12/23/1998	SE4	2960	025	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_Approv.pdf	12/23/1998
AP	12/23/1998	SE4	2961	025	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612S025_Nicorette_prntlbl.pdf	12/23/1998
AP	12/23/1998	SE4	2962	025	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18-612s025_Nicorette.cfm	12/23/1998
AP	8/24/2001	SLR
AP	9/25/2000	SCF
AP	8/9/2002	SLR	2955	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18612slr031,%2020066slr013ltr.pdf	8/9/2002
AP	11/15/2002	SCS
AP	4/23/2004	SCF	8435	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf034ltr.pdf	4/29/2004
AP	4/23/2004	SCF	17118	034	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018612_S034_NICORETTE_GUM_AP.pdf	7/6/2007
AP	6/23/2004	SLR	9532	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612slr035ltr.pdf	6/24/2004
AP	6/18/2004	SCF	9501	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18612scf037ltr.pdf	6/23/2004
AP	12/2/2005	SCF	13241	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018612s042,020066s023lbl.pdf	12/13/2005
AP	12/2/2005	SCF	13249	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018612s042,020066s023ltr.pdf	12/13/2005
AP	5/4/2006	SCP	14057	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018612s043,020066s024LTR.pdf	5/5/2006
AP	6/26/2007	SLR	16851	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018612s049,02066s030lbl.pdf	6/27/2007
AP	6/26/2007	SLR	16893	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018612s049, 020066s030ltr.pdf	7/5/2007
AP	6/13/2008	SCF	20019	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018612s050, 020066s031ltr.pdf	6/16/2008
AP	6/13/2008	SCF	32204	050	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/018612Orig1s050.pdf	3/27/2012
AP	5/6/2009	SE8	22470	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018612s052,020066s033ltr.pdf	5/8/2009
AP	5/17/2011	SLR	28863	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s056,020066s037ltr.pdf	5/19/2011
AP	9/27/2011	SLR	30140	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018612s057ltr.pdf	9/29/2011
AP	9/12/2011	SCM
AP	2/1/2012	SLR	31651	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s060,020066s041ltr.pdf	2/3/2012
AP	2/15/2012	SLR	31809	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612s061,020066s042ltr.pdf	2/17/2012
AP	2/15/2012	SLR	32260	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612s061_020066s042lbl.pdf	3/28/2012
AP	7/16/2012	SLR	33221	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018612Orig1s065,020066Orig1s046ltr.pdf	7/18/2012
AP	7/16/2012	SLR	38300	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018612Orig1s065, 020066Orig1s046lbl.pdf	1/16/2014
AP	8/1/2012	SCM
AP	10/30/2013	SLR	37629	068	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018612Orig1s068,020066Orig1s049ltr.pdf	10/31/2013
AP	10/30/2013	SLR	37731	068	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018612Orig1s068,020066Orig1s049lbl.pdf	11/7/2013
AP	10/11/2013	SCM
AP	4/17/2014	SCM
AP	2/21/2014	SCM
AP	6/11/2014	SLR	39534	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf	6/12/2014
AP	6/11/2014	SLR	40141	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf	8/5/2014
AP	6/11/2014	SLR	39535	073	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s072,s073,020066Orig1s053,s054ltr.pdf	6/12/2014
AP	6/11/2014	SLR	40142	073	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s072, s073, 020066Orig1s053, s054lbl .pdf	8/5/2014
AP	10/30/2014	SLR	40923	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018612Orig1s074,020066Orig1s055ltr.pdf	11/3/2014
AP	10/30/2014	SLR	40968	074	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018612Orig1s074, 020066Orig1s055lbl.pdf	11/7/2014
AP	1/5/2015	SCM
AP	9/30/2015	SLR	44082	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018612Orig1s076,020066Orig1s057ltr.pdf	10/2/2015
AP	9/30/2015	SLR	44343	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018612s076lbl.pdf	11/2/2015
AP	9/10/2015	SCM

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