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FDA Drug Application 018780 by LILLY

Application Number	018780
Application Type	New Drug Application
Sponsor Applicant	LILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
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	3/14/1983	SCS
AP	0	8/24/1983	SLR
AP	0	10/12/1983	SLR
AP	0	7/25/1984	SCS
AP	0	1/26/1984	SCS
AP	0	2/28/1984	SLR
AP	0	12/26/1984	SCS
AP	0	11/23/1984	SCS
AP	0	3/8/1985	SCS
AP	0	4/10/1986	SCS
AP	0	9/15/1986	SCS
AP	0	7/28/1987	SLR
AP	0	5/7/1987	SCS
AP	0	7/13/1987	SLR
AP	0	5/28/1986	SCS
AP	0	7/10/1987	SLR
AP	0	6/10/1988	SCS
AP	0	10/27/1987	SCM
AP	0	3/24/1988	SLR
AP	0	2/1/1989	SCS
AP	0	7/29/1988	SCS
AP	0	1/23/1989	SLR
AP	0	8/17/1990	SCS
AP	0	9/24/1990	SCS
AP	0	11/15/1991	SCS
AP	0	3/12/1991	SLR
AP	0	1/11/1994	SCP	5929	037	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018780_s037.pdf	6/17/2003
AP	0	1/27/1992	SLR
AP	0	6/14/1994	SCS
AP	0	5/10/1993	SCM
AP	0	12/7/1992	SCP
AP	0	3/31/1994	SE2
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	2/14/1996	SCS
AP	0	2/15/1996	SCS
AP	0	4/25/1996	SCM
AP	0	7/26/1996	SCS
AP	0	7/10/1996	SLR
AP	0	7/26/1996	SCS
AP	0	1/28/1997	SCM
AP	0	4/16/1997	SLR
AP	0	4/16/1997	SCS
AP	1	9/22/2016	SCM
AP	0	2/20/1998	SCS
AP	0	8/6/1998	SCP
AP	0	2/25/1999	SCS
AP	0	11/2/1999	SCS
AP	0	4/19/2000	SCS
AP	0	8/29/2002	SCS
AP	0	4/14/2003	SLR	5702	066	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780slr066ltr.pdf	5/29/2003
AP	0	2/10/2003	SLR	4140	067	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf	3/5/2003
AP	0	2/10/2003	SLR	9062	067	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf	6/7/2004
AP	0	3/13/2002	SCS
AP	0	10/10/2002	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	10/25/2002	SCS
AP	0	2/10/2003	SCM	4139	078	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf	3/5/2003
AP	0	2/10/2003	SCM	9063	078	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf	6/7/2004
AP	0	11/10/2003	SCM	6951	080	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm080ltr.pdf	11/25/2003
AP	0	11/10/2003	SCM	7003	080	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf	12/1/2003
AP	0	2/25/2005	SCS	11193	086	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf	3/3/2005
AP	0	2/25/2005	SCS	11203	086	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf	3/3/2005
AP	0	9/7/2007	SLR	17861	094	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf	9/11/2007
AP	0	8/22/2007	SLR	17702	095	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf	8/23/2007
AP	0	8/22/2007	SLR	17721	095	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf	8/27/2007
AP	0	9/10/2007	SLR	17839	114	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf	9/11/2007
AP	0	9/10/2007	SLR	17854	114	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s114ltr.pdf	9/11/2007
AP	0	3/25/2011	SE3	28402	120	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s120ltr.pdf	3/29/2011
AP	0	3/25/2011	SE3	28424	120	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf	4/1/2011
AP	0	3/21/2011	SLR	28319	124	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s124ltr.pdf	3/24/2011
AP	0	3/21/2011	SLR	28383	124	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s124lbl.pdf	3/28/2011
AP	0	3/29/2012	SCM
AP	0	6/10/2010	SLR	25737	128	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf	6/15/2010
AP	0	6/10/2010	SLR	25778	128	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf	6/24/2010
AP	0	3/9/2013	SLR	35400	132	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018780Orig1s132ltr.pdf	3/12/2013
AP	0	3/9/2013	SLR	35441	132	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf	3/12/2013
AP	0	10/30/2011	SLR	30459	133	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s133ltr.pdf	11/2/2011
AP	0	12/29/2015	SLR	44918	135	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf	12/30/2015
AP	0	12/29/2015	SLR	44929	135	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf	12/31/2015
AP	0	1/9/2013	SCM
AP	0	11/7/2012	SCM
AP	0	5/10/2013	SCM
AP	0	5/30/2013	SCM
AP	0	5/31/2013	SCM
AP	0	8/15/2013	SCM
AP	0	3/18/2014	SCM
AP	0	6/20/2014	SCM
AP	0	9/23/2014	SCM	40619	148	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf	9/26/2014
AP	0	10/30/2014	SCM
AP	1	2/25/2015	SLR	41994	150	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf	3/3/2015
AP	1	2/25/2015	SLR	42355	150	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s150ltr.pdf	4/1/2015
AP	0	10/8/2015	SCM
AP	0	12/29/2015	SLR	44917	152	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf	12/30/2015
AP	0	12/29/2015	SLR	44930	152	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf	12/31/2015
AP	0	7/8/2016	SLR	46497	153	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018780Orig1s153ltr.pdf	7/12/2016
AP	0	2/26/2016	SCM
AP	0	6/24/2016	SCM

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