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FDA Drug Application 018781 by LILLY

Application Number	018781
Application Type	New Drug Application
Sponsor Applicant	LILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	10/28/1982	N
AP	0	12/2/1982	SLR
AP	0	12/2/1982	SCF
AP	0	1/31/1983	SCS
AP	0	1/27/1983	SLR
AP	0	8/24/1983	SLR
AP	0	10/12/1983	SLR
AP	0	7/25/1984	SCS
AP	0	2/29/1984	SLR
AP	0	2/14/1985	SCS
AP	0	12/26/1984	SCS
AP	0	6/28/1988	SCS
AP	0	7/31/1987	SLR
AP	0	10/27/1987	SCF
AP	0	7/28/1987	SLR
AP	0	7/13/1987	SLR
AP	0	7/13/1987	SLR
AP	0	7/10/1987	SLR
AP	0	10/27/1987	SCM
AP	0	10/27/1987	SCS
AP	0	10/27/1987	SCM
AP	0	3/24/1988	SLR
AP	0	3/3/1988	SCS
AP	0	7/29/1988	SCS
AP	0	1/23/1989	SLR
AP	0	4/3/1991	SLR	23323	027	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018781_s027_Humulin N.pdf	9/16/2009
AP	0	8/17/1990	SCS
AP	0	9/24/1990	SCS
AP	0	3/12/1991	SLR
AP	0	1/11/1994	SCP
AP	0	12/7/1992	SCP
AP	0	10/27/1995	SCF
AP	0	2/10/1995	SCM
AP	0	2/22/1995	SLR
AP	0	3/9/1995	SCS
AP	0	9/29/1995	SLR
AP	0	11/9/1995	SLR
AP	0	2/15/1996	SCS
AP	0	1/26/1996	SCM
AP	0	5/31/1996	SCS
AP	0	5/22/1996	SCS
AP	0	7/26/1996	SCS
AP	0	7/10/1996	SLR
AP	0	1/28/1997	SCM
AP	0	4/16/1997	SLR
AP	0	2/20/1998	SCS
AP	0	6/24/1997	SCP
AP	0	8/6/1998	SCP
AP	0	2/25/1999	SCS
AP	0	11/5/2002	SLR	2260	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18781slr054ltr.pdf	11/5/2002
AP	0	10/29/1999	SCS
AP	0	7/7/2000	SCM
AP	0	2/12/2003	SLR	4129	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf	3/5/2003
AP	0	2/12/2003	SLR	9060	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf	6/7/2004
AP	0	11/20/2003	SLR	6962	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf	11/25/2003
AP	0	4/2/2002	SCS
AP	0	10/31/2002	SCS
AP	0	8/21/2002	SCS
AP	0	8/21/2002	SCS
AP	0	8/29/2002	SCS
AP	0	8/29/2002	SCS
AP	0	8/29/2002	SCS
AP	0	11/20/2003	SLR	6963	070	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf	11/25/2003
AP	0	6/22/2003	SLR	6039	072	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr072ltr.pdf	7/6/2003
AP	0	6/22/2003	SLR	6077	072	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781slr072_humulin_lbl.pdf	7/8/2003
AP	0	11/19/2003	SCM	6931	074	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781scm074ltr.pdf	11/25/2003
AP	0	11/19/2003	SCM	7014	074	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf	12/2/2003
AP	0	4/21/2004	SLR	8437	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781slr076ltr.pdf	4/29/2004
AP	0	4/21/2004	SLR	8482	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf	5/4/2004
AP	0	8/27/2004	SLR	10140	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf	9/7/2004
AP	0	8/27/2004	SLR	10141	079	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf	9/7/2004
AP	1	9/3/2004	SLR	10140	079	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf	9/7/2004
AP	1	9/3/2004	SLR	10141	079	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf	9/7/2004
AP	0	2/25/2005	SCS	11194	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf	3/3/2005
AP	0	2/25/2005	SCS	11204	080	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf	3/3/2005
AP	0	11/9/2005	SLR	13066	085	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf	11/17/2005
AP	0	11/9/2005	SLR	13086	085	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018781s025,060,065,085ltr.pdf	11/18/2005
AP	0	9/7/2007	SLR	17860	088	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf	9/11/2007
AP	0	8/22/2007	SLR	17701	089	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf	8/23/2007
AP	0	8/22/2007	SLR	17720	089	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf	8/27/2007
AP	0	3/16/2009	SCS	22026	108	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf	3/17/2009
AP	0	3/16/2009	SCS	22074	108	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf	3/23/2009
AP	0	3/21/2012	SCM
AP	0	6/10/2010	SLR	25738	114	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf	6/15/2010
AP	0	6/10/2010	SLR	25777	114	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf	6/24/2010
AP	0	11/7/2013	SLR	37783	118	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf	11/12/2013
AP	0	11/7/2013	SLR	37829	118	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	1	11/7/2013	SLR	37783	118	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf	11/12/2013
AP	1	11/7/2013	SLR	37829	118	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	0	9/30/2014	SCM	40701	120	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf	10/2/2014
AP	0	3/9/2013	SLR	35399	121	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s121ltr.pdf	3/12/2013
AP	0	3/9/2013	SLR	35440	121	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf	3/12/2013
AP	0	11/7/2013	SLR	37782	122	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf	11/12/2013
AP	0	11/7/2013	SLR	37830	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	0	11/7/2013	SLR	37831	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	1	11/7/2013	SLR	37782	122	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf	11/12/2013
AP	1	11/7/2013	SLR	37830	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	1	11/7/2013	SLR	37831	122	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf	11/15/2013
AP	0	12/3/2012	SCM
AP	0	6/12/2013	SCM
AP	0	2/15/2013	SCM
AP	0	5/10/2013	SCM
AP	0	3/25/2013	SCM
AP	0	2/21/2013	SCM
AP	0	8/21/2013	SCM
AP	0	5/30/2013	SCM
AP	0	5/31/2013	SCM
AP	0	8/15/2013	SCM
AP	0	12/12/2013	SCM
AP	0	3/4/2014	SCM
AP	0	3/18/2014	SCM
AP	0	1/24/2014	SCM
AP	0	4/3/2014	SCM
AP	0	4/11/2014	SCM
AP	0	12/9/2013	SLR	38020	144	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s144ltr.pdf	12/13/2013
AP	0	1/15/2014	SLR	38312	145	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018781Orig1s145ltr.pdf	1/17/2014
AP	0	6/10/2014	SCM
AP	0	6/4/2014	SCM
AP	0	9/12/2014	SCM
AP	0	1/12/2015	SCM
AP	0	2/25/2015	SLR	41920	154	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s154ltr.pdf	2/27/2015
AP	0	2/25/2015	SLR	42758	154	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf	5/8/2015
AP	0	3/3/2015	SCM
AP	0	3/12/2015	SLR	42145	156	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s156ltr.pdf	3/13/2015
AP	0	3/12/2015	SLR	42174	156	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s156lbl.pdf	3/17/2015
AP	0	7/15/2015	SCM
AP	0	10/8/2015	SCM
AP	0	10/20/2015	SCM
AP	0	2/19/2016	SCM
AP	0	4/22/2016	SCM
AP	0	4/5/2016	SCM
AP	0	9/2/2016	SCM

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