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FDA Drug Application 020563 by LILLY

Application Number	020563
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	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	6/14/1996	N
AP	1/9/1997	SLR
AP	3/5/1997	SCM
AP	7/16/1997	SLR	4289	003	http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf	7/16/1997
AP	2/20/1998	SCP
AP	4/29/1997	SCM
AP	8/6/1998	SCP
AP	9/4/1998	SCP	17181	009	http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf	7/9/2007
AP	4/4/2000	SE2	1057	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF	4/4/2000
AP	4/4/2000	SE2	1058	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF	4/4/2000
AP	4/4/2000	SE8	1059	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF	4/4/2000
AP	4/4/2000	SE8	1060	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF	4/4/2000
AP	4/4/2000	SE1	1061	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF	4/4/2000
AP	4/4/2000	SE1	1062	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF	4/4/2000
AP	4/4/2000	SE8	1063	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF	4/4/2000
AP	4/4/2000	SE8	1064	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF	4/4/2000
AP	2/25/1999	SCS
AP	2/25/1999	SCM	4274	015	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf	3/11/2003
AP	1/2/2003	SLR	9057	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf	6/7/2004
AP	5/12/1999	SCS
AP	1/11/2000	SCM
AP	2/25/2000	SCM
AP	5/23/2000	SCM
AP	6/2/2004	SE3	9097	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563se3-024ltr.pdf	6/7/2004
AP	6/2/2004	SE3	9124	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf	6/7/2004
AP	3/14/2000	SCS
AP	7/7/2000	SCM
AP	3/12/2003	SLR	4122	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf	3/5/2003
AP	3/12/2003	SLR	9061	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf	6/7/2004
AP	9/11/2000	SCS
AP	3/26/2001	SCS
AP	5/11/2001	SCM
AP	4/1/2003	SLR	4852	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf	4/3/2003
AP	4/1/2003	SLR	5293	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr032ltr.pdf	4/16/2003
AP	12/17/2001	SCS
AP	2/5/2002	SCS
AP	10/25/2002	SE1
AP	1/16/2004	SLR	7588	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr036ltr.pdf	1/22/2004
AP	1/16/2004	SLR	7612	036	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf	1/22/2004
AP	6/24/2003	SLR	6055	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr040ltr.pdf	7/6/2003
AP	6/24/2003	SLR	6078	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf	7/8/2003
AP	9/29/2003	SCM	6736	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf	10/8/2003
AP	9/29/2003	SCM	6745	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf	10/9/2003
AP	11/19/2003	SCM	6950	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm044ltr.pdf	11/25/2003
AP	11/19/2003	SCM	9056	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf	6/7/2004
AP	4/21/2004	SLR	8449	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr046ltr.pdf	4/29/2004
AP	4/21/2004	SLR	8486	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf	5/4/2004
AP	7/31/2014	SCM
AP	5/20/2005	SLR	11696	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020563s054ltr.pdf	5/23/2005
AP	5/20/2005	SLR	11697	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf	5/23/2005
AP	11/9/2005	SLR
AP	9/7/2007	SLR	17857	064	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf	9/11/2007
AP	8/22/2007	SLR	17696	065	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf	8/23/2007
AP	8/22/2007	SLR	17717	065	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf	8/27/2007
AP	9/6/2007	SCP	17827	075	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf	9/11/2007
AP	9/6/2007	SCP	17868	075	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf	9/11/2007
AP	6/14/2007	SLR	16829	076	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf	6/27/2007
AP	6/14/2007	SLR	16926	076	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s076ltr.pdf	7/5/2007
AP	7/20/2007	SLR	17332	082	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf	7/24/2007
AP	7/20/2007	SLR	17350	082	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf	7/24/2007
AP	3/16/2009	SCS	22027	091	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf	3/17/2009
AP	3/16/2009	SCS	22071	091	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020563s091,021017s053,021018s049ltr.pdf	3/23/2009
AP	5/18/2011	SLR	28896	098	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf	5/23/2011
AP	5/18/2011	SLR	28919	098	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf	5/24/2011
AP	5/18/2011	SE5	28897	105	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf	5/23/2011
AP	5/18/2011	SE5	28920	105	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf	5/24/2011
AP	3/11/2013	SLR	35418	115	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf	3/11/2013
AP	3/11/2013	SLR	35443	115	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s115ltr.pdf	3/13/2013
AP	10/30/2011	SLR	30635	117	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf	11/16/2011
AP	10/12/2012	SE3	34097	123	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf	10/15/2012
AP	10/12/2012	SE3	34108	123	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf	10/16/2012
AP	3/13/2015	SLR	42151	124	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf	3/16/2015
AP	3/13/2015	SLR	42450	124	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf	4/7/2015
AP	1/30/2013	SLR	35029	127	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s127ltr.pdf	1/31/2013
AP	1/30/2013	SLR	35033	127	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf	2/1/2013
AP	6/12/2013	SCM
AP	2/15/2013	SCM
AP	9/6/2013	SCM
AP	5/10/2013	SCM
AP	3/14/2013	SCM
AP	3/28/2013	SCM
AP	8/21/2013	SCM
AP	7/18/2013	SCM
AP	8/15/2013	SCM
AP	1/31/2014	SCM
AP	3/4/2014	SCM
AP	3/18/2014	SCM
AP	1/24/2014	SCM
AP	4/1/2014	SCM
AP	4/3/2014	SCM
AP	4/11/2014	SCM
AP	6/4/2014	SCM
AP	9/12/2014	SCM
AP	11/11/2014	SCM
AP	1/26/2015	SCM
AP	2/25/2015	SLR	41923	157	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s157ltr.pdf	2/27/2015
AP	2/25/2015	SLR	41966	157	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf	3/2/2015
AP	6/11/2015	SCM
AP	9/10/2015	SCM
AP	6/12/2015	SLR	43060	163	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf	6/15/2015
AP	6/12/2015	SLR	43063	163	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf	6/15/2015
AP	9/22/2016	SCM
AP	10/17/2016	SCM

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