BLA 018781

LILLY

FDA Drug Application

Application #018781

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
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• Other: 2020-03-23
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• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-22
• Letter: 2022-06-28
• Label: 2022-06-30

Application Sponsors

BLA 018781

LILLY

Marketing Status

• Over-the-counter: 001

Application Products

001

INJECTABLE;INJECTION

100 UNITS/ML

0

HUMULIN N

INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1982-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-01-31	STANDARD
LABELING; Labeling	SUPPL	4	AP	1983-01-27
LABELING; Labeling	SUPPL	5	AP	1983-08-24
LABELING; Labeling	SUPPL	6	AP	1983-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-07-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	1984-02-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-06-28	STANDARD
LABELING; Labeling	SUPPL	14	AP	1987-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-10-27	STANDARD
LABELING; Labeling	SUPPL	16	AP	1987-07-28
LABELING; Labeling	SUPPL	17	AP	1987-07-13
LABELING; Labeling	SUPPL	18	AP	1987-07-13
LABELING; Labeling	SUPPL	19	AP	1987-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1987-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-10-27	STANDARD
LABELING; Labeling	SUPPL	23	AP	1988-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-07-29	STANDARD
LABELING; Labeling	SUPPL	26	AP	1989-01-23
LABELING; Labeling	SUPPL	27	AP	1991-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1990-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-09-24	STANDARD
LABELING; Labeling	SUPPL	30	AP	1991-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1994-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1992-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1995-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1995-02-10	STANDARD
LABELING; Labeling	SUPPL	35	AP	1995-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1995-03-09	STANDARD
LABELING; Labeling	SUPPL	37	AP	1995-09-29	STANDARD
LABELING; Labeling	SUPPL	38	AP	1995-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1996-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1996-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1996-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1996-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1996-07-26	STANDARD
LABELING; Labeling	SUPPL	44	AP	1996-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1997-01-28	STANDARD
LABELING; Labeling	SUPPL	47	AP	1997-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1998-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1997-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1998-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1999-02-25	STANDARD
LABELING; Labeling	SUPPL	54	AP	2002-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1999-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2000-07-07	STANDARD
LABELING; Labeling	SUPPL	57	AP	2003-02-12	STANDARD
LABELING; Labeling	SUPPL	60	AP	2003-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	2002-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2002-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	2002-08-29	STANDARD
LABELING; Labeling	SUPPL	70	AP	2003-11-20	STANDARD
LABELING; Labeling	SUPPL	72	AP	2003-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2003-11-19	STANDARD
LABELING; Labeling	SUPPL	76	AP	2004-04-21	STANDARD
LABELING; Labeling	SUPPL	79	AP	2004-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2005-02-25	STANDARD
LABELING; Labeling	SUPPL	85	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	88	AP	2007-09-07	STANDARD
LABELING; Labeling	SUPPL	89	AP	2007-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	108	AP	2009-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	113	AP	2012-03-21	STANDARD
LABELING; Labeling	SUPPL	114	AP	2010-06-10	UNKNOWN
LABELING; Labeling	SUPPL	118	AP	2013-11-07	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	120	AP	2014-09-30	STANDARD
LABELING; Labeling	SUPPL	121	AP	2013-03-09	UNKNOWN
LABELING; Labeling	SUPPL	122	AP	2013-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	125	AP	2012-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	126	AP	2013-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	128	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	129	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	130	AP	2013-03-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	131	AP	2013-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	132	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	133	AP	2013-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	134	AP	2013-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	136	AP	2013-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	137	AP	2013-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	139	AP	2014-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	140	AP	2014-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	141	AP	2014-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	2014-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	143	AP	2014-04-11	STANDARD
LABELING; Labeling	SUPPL	144	AP	2013-12-09	STANDARD
LABELING; Labeling	SUPPL	145	AP	2014-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	2014-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	147	AP	2014-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	150	AP	2014-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	153	AP	2015-01-12	STANDARD
LABELING; Labeling	SUPPL	154	AP	2015-02-25	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	155	AP	2015-03-03	STANDARD
LABELING; Labeling	SUPPL	156	AP	2015-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	157	AP	2015-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	158	AP	2015-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	159	AP	2015-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	160	AP	2016-02-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	161	AP	2016-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	163	AP	2016-04-05	STANDARD
LABELING; Labeling	SUPPL	167	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	181	AP	2018-11-06	STANDARD
LABELING; Labeling	SUPPL	184	AP	2019-08-22	STANDARD
LABELING; Labeling	SUPPL	187	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	188	AP	2019-11-15	901 REQUIRED
LABELING; Labeling	SUPPL	193	AP	2022-06-27	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	53	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	74	Null	0
SUPPL	80	Null	0
SUPPL	108	Null	0
SUPPL	113	Null	0
SUPPL	114	Null	6
SUPPL	118	Null	6
SUPPL	120	Null	0
SUPPL	121	Null	15
SUPPL	122	Null	15
SUPPL	125	Null	0
SUPPL	126	Null	0
SUPPL	128	Null	0
SUPPL	129	Null	0
SUPPL	130	Null	0
SUPPL	131	Null	0
SUPPL	132	Null	0
SUPPL	133	Null	0
SUPPL	134	Null	0
SUPPL	136	Null	0
SUPPL	137	Null	0
SUPPL	139	Null	0
SUPPL	140	Null	0
SUPPL	141	Null	0
SUPPL	142	Null	0
SUPPL	143	Null	0
SUPPL	144	Null	15
SUPPL	145	Null	6
SUPPL	146	Null	0
SUPPL	147	Null	0
SUPPL	150	Null	0
SUPPL	153	Null	0
SUPPL	154	Null	15
SUPPL	155	Null	0
SUPPL	156	Null	15
SUPPL	157	Null	0
SUPPL	158	Null	0
SUPPL	159	Null	0
SUPPL	160	Null	0
SUPPL	161	Null	0
SUPPL	163	Null	0
SUPPL	167	Null	6
SUPPL	181	Null	15
SUPPL	184	Null	7
SUPPL	187	Null	6
SUPPL	188	Null	7
SUPPL	193	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18781
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)