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FDA Drug Application 018081 by ABBVIE

Application Number	018081
Application Type	New Drug Application
Sponsor Applicant	ABBVIE
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	2/28/1978	N	19048	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm	2/1/2008
AP	2/28/1978	N	35366	000	http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf	3/8/2013
AP	5/3/1979	SLR
AP	12/20/1979	SCS
AP	12/20/1979	SCF
AP	6/16/1980	SCE
AP	12/9/1981	SLR
AP	11/4/1981	SLR
AP	12/9/1981	SLR
AP	9/30/1982	SCE
AP	10/28/1983	SCM
AP	5/30/1986	SLR
AP	12/4/1985	SLR
AP	5/30/1986	SLR
AP	8/11/1986	SLR
AP	12/2/1987	SCM
AP	3/21/1989	SCM
AP	3/23/1995	SCS
AP	12/2/1996	SCS
AP	5/16/2000	SLR
AP	5/8/1998	SCP
AP	9/22/1998	SCM
AP	6/19/2000	SLR
AP	12/6/1999	SCS
AP	6/20/2000	SCS
AP	12/20/2000	SCM
AP	6/20/2000	SCS
AP	12/12/2002	SLR	8886	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116	6/2/2004
AP	1/11/2006	SLR	13388	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf	1/13/2006
AP	1/11/2006	SLR	13445	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s042ltr.pdf	1/20/2006
AP	10/13/2006	SLR	15118	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf	10/18/2006
AP	10/13/2006	SLR	15198	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf	10/23/2006
AP	10/7/2011	SLR	30278	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf	10/12/2011
AP	10/7/2011	SLR	30299	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf	10/13/2011
AP	4/23/2009	SLR	22377	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032ltr.pdf	5/1/2009
AP	10/7/2011	SLR	30279	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf	10/12/2011
AP	10/7/2011	SLR	30300	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf	10/13/2011
AP	6/19/2014	SLR	39612	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf	6/23/2014
AP	6/19/2014	SLR	39639	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf	6/23/2014
AP	10/7/2011	SLR	30280	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf	10/12/2011
AP	10/7/2011	SLR	30301	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf	10/13/2011
AP	10/7/2011	SLR	30281	052	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf	10/12/2011
AP	10/7/2011	SLR	30302	052	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf	10/13/2011
AP	2/27/2013	SLR	35282	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf	3/1/2013
AP	2/27/2013	SLR	35329	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.pdf	3/4/2013
AP	7/31/2013	SLR	37142	056	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s056lbl.pdf	9/17/2013
AP	7/31/2013	SLR	37143	056	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf	9/17/2013
AP	6/14/2013	SLR	36416	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.pdf	7/2/2013
AP	11/20/2014	SLR	41074	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf	11/24/2014
AP	11/20/2014	SLR	41146	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf	12/3/2014
AP	1/7/2015	SLR	41522	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf	1/8/2015
AP	1/7/2015	SLR	41534	059	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf	1/8/2015
AP	6/9/2014	SLR	39476	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf	6/10/2014
AP	6/9/2014	SLR	39514	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf	6/11/2014
AP	8/20/2014	SLR	40290	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf	8/21/2014
AP	8/20/2014	SLR	40308	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf	8/22/2014
AP	3/13/2015	SLR	42155	062	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf	3/17/2015
AP	3/13/2015	SLR	42183	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf	3/17/2015
AP	9/23/2015	SLR	43991	063	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf	9/25/2015
AP	9/23/2015	SLR	44139	063	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf	10/6/2015
AP	2/18/2016	SLR	45223	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf	2/23/2016
AP	2/18/2016	SLR	45236	064	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf	2/23/2016

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