BLA 020563

LILLY

FDA Drug Application

Application #020563

Documents

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Application Sponsors

BLA 020563

LILLY

Marketing Status

• Prescription: 001
• Discontinued: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	100 UNITS/ML	0	HUMALOG	INSULIN LISPRO RECOMBINANT
002	INJECTABLE;INJECTION	100 UNITS/ML	0	HUMALOG PEN	INSULIN LISPRO RECOMBINANT
003	INJECTABLE;INJECTION	100 UNITS/ML	0	HUMALOG KWIKPEN	INSULIN LISPRO RECOMBINANT
004	INJECTABLE;INJECTION	200UNITS/ML	0	HUMALOG KWIKPEN	INSULIN LISPRO RECOMBINANT
005	INJECTABLE;INJECTION	100UNITS/ML	0	HUMALOG TEMPO PEN	INSULIN LISPRO RECOMBINANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-03-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	1997-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-09-04	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2000-04-04	UNKNOWN
EFFICACY; Efficacy	SUPPL	11	AP	2000-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2000-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2000-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-02-25	STANDARD
LABELING; Labeling	SUPPL	16	AP	2003-01-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2000-05-23	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2004-06-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2000-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2000-07-07	STANDARD
LABELING; Labeling	SUPPL	27	AP	2003-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-03-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2001-05-11	STANDARD
LABELING; Labeling	SUPPL	32	AP	2003-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2001-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-02-05	STANDARD
EFFICACY; Efficacy	SUPPL	35	AP	2002-10-25	STANDARD
LABELING; Labeling	SUPPL	36	AP	2004-01-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2003-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2003-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2003-11-19	STANDARD
LABELING; Labeling	SUPPL	46	AP	2004-04-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2014-07-31	STANDARD
LABELING; Labeling	SUPPL	54	AP	2005-05-20	STANDARD
LABELING; Labeling	SUPPL	60	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	64	AP	2007-09-07	STANDARD
LABELING; Labeling	SUPPL	65	AP	2007-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	2007-09-06	STANDARD
LABELING; Labeling	SUPPL	76	AP	2007-06-14	STANDARD
LABELING; Labeling	SUPPL	82	AP	2007-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	2009-03-16	STANDARD
LABELING; Labeling	SUPPL	98	AP	2011-05-18	UNKNOWN
EFFICACY; Efficacy	SUPPL	105	AP	2011-05-18	STANDARD
LABELING; Labeling	SUPPL	115	AP	2013-03-11	STANDARD
LABELING; Labeling	SUPPL	117	AP	2011-10-30	STANDARD
EFFICACY; Efficacy	SUPPL	123	AP	2012-10-14	STANDARD
LABELING; Labeling	SUPPL	124	AP	2015-03-13	STANDARD
LABELING; Labeling	SUPPL	127	AP	2013-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	131	AP	2013-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	132	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	133	AP	2013-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	134	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	135	AP	2013-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	137	AP	2013-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	139	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	141	AP	2013-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	2013-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	143	AP	2014-01-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	144	AP	2014-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	145	AP	2014-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	2014-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	147	AP	2014-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	148	AP	2014-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	2014-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	150	AP	2014-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	152	AP	2014-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	155	AP	2014-11-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	156	AP	2015-01-26	STANDARD
LABELING; Labeling	SUPPL	157	AP	2015-02-25	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	159	AP	2015-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	161	AP	2015-09-10	STANDARD
LABELING; Labeling	SUPPL	163	AP	2015-06-12	STANDARD
LABELING; Labeling	SUPPL	172	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	176	AP	2017-06-06	STANDARD
LABELING; Labeling	SUPPL	190	AP	2018-12-11	STANDARD
LABELING; Labeling	SUPPL	191	AP	2018-11-01	STANDARD
LABELING; Labeling	SUPPL	195	AP	2019-08-13	STANDARD
LABELING; Labeling	SUPPL	196	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	198	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	199	AP	2019-11-15	901 REQUIRED

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0
SUPPL	51	Null	0
SUPPL	75	Null	0
SUPPL	91	Null	0
SUPPL	98	Null	6
SUPPL	105	Null	6
SUPPL	115	Null	15
SUPPL	117	Null	7
SUPPL	123	Null	6
SUPPL	124	Null	7
SUPPL	127	Null	6
SUPPL	131	Null	0
SUPPL	132	Null	0
SUPPL	133	Null	0
SUPPL	134	Null	0
SUPPL	135	Null	0
SUPPL	137	Null	0
SUPPL	139	Null	0
SUPPL	141	Null	0
SUPPL	142	Null	0
SUPPL	143	Null	0
SUPPL	144	Null	0
SUPPL	145	Null	0
SUPPL	146	Null	0
SUPPL	147	Null	0
SUPPL	148	Null	0
SUPPL	149	Null	0
SUPPL	150	Null	0
SUPPL	152	Null	0
SUPPL	155	Null	0
SUPPL	156	Null	0
SUPPL	157	Null	15
SUPPL	159	Null	0
SUPPL	161	Null	0
SUPPL	163	Null	15
SUPPL	172	Null	7
SUPPL	176	Null	15
SUPPL	190	Null	15
SUPPL	191	Null	15
SUPPL	195	Null	6
SUPPL	196	Null	4
SUPPL	198	Null	6
SUPPL	199	Null	7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20563
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)