BLA 018780

LILLY

FDA Drug Application

Application #018780

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
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• Label: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Letter: 2020-03-23
• Label: 2020-08-17
• Other: 2020-03-23
• Letter: 2022-06-28
• Label: 2022-06-30

Application Sponsors

BLA 018780

LILLY

Marketing Status

• Over-the-counter: 001
• Prescription: 002
• Prescription: 004
• Over-the-counter: 005

Application Products

001	INJECTABLE;INJECTION	100 UNITS/ML	0	HUMULIN R	INSULIN RECOMBINANT HUMAN
002	SOLUTION;SUBCUTANEOUS	1500 UNITS/3ML (500 UNITS/ML)	0	HUMULIN R KWIKPEN	INSULIN HUMAN
004	SOLUTION;SUBCUTANEOUS	10000 UNITS/20ML (500 UNITS/ML)	0	HUMULIN R	INSULIN HUMAN
005	INJECTABLE;INJECTION	100 UNITS/ML	0	HUMULIN R PEN	INSULIN RECOMBINANT HUMAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	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
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-03-14	STANDARD
LABELING; Labeling	SUPPL	7	AP	1983-08-24
LABELING; Labeling	SUPPL	8	AP	1983-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-07-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-01-26	STANDARD
LABELING; Labeling	SUPPL	12	AP	1984-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-11-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1986-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1986-09-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	1987-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-05-07	STANDARD
LABELING; Labeling	SUPPL	23	AP	1987-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1986-05-28	STANDARD
LABELING; Labeling	SUPPL	26	AP	1987-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1988-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1987-10-27	STANDARD
LABELING; Labeling	SUPPL	29	AP	1988-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1989-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1988-07-29	STANDARD
LABELING; Labeling	SUPPL	32	AP	1989-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1990-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1990-09-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1991-11-15	STANDARD
LABELING; Labeling	SUPPL	36	AP	1991-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1994-01-11	STANDARD
LABELING; Labeling	SUPPL	38	AP	1992-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1994-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1993-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-12-07	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	1994-03-31	UNKNOWN
LABELING; Labeling	SUPPL	43	AP	1995-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1995-03-09	STANDARD
LABELING; Labeling	SUPPL	45	AP	1995-09-29	STANDARD
LABELING; Labeling	SUPPL	46	AP	1995-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1996-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1996-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1996-04-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1996-07-26	STANDARD
LABELING; Labeling	SUPPL	51	AP	1996-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1996-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1997-01-28	STANDARD
LABELING; Labeling	SUPPL	55	AP	1997-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1997-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1998-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1998-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1999-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1999-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	2000-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2002-08-29	STANDARD
LABELING; Labeling	SUPPL	66	AP	2003-04-14	STANDARD
LABELING; Labeling	SUPPL	67	AP	2003-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	2002-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2002-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	75	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	2002-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	2003-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2003-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	86	AP	2005-02-25	STANDARD
LABELING; Labeling	SUPPL	94	AP	2007-09-07	STANDARD
LABELING; Labeling	SUPPL	95	AP	2007-08-22	STANDARD
LABELING; Labeling	SUPPL	114	AP	2007-09-10	STANDARD
EFFICACY; Efficacy	SUPPL	120	AP	2011-03-25	STANDARD
LABELING; Labeling	SUPPL	124	AP	2011-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	126	AP	2018-05-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	127	AP	2012-03-29	STANDARD
LABELING; Labeling	SUPPL	128	AP	2010-06-10	UNKNOWN
LABELING; Labeling	SUPPL	132	AP	2013-03-09	STANDARD Label for HUMULIN R U- 100
LABELING; Labeling	SUPPL	133	AP	2011-10-30	STANDARD
LABELING; Labeling	SUPPL	134	AP	2018-05-25	STANDARD
LABELING; Labeling	SUPPL	135	AP	2015-12-29	STANDARD Label for HUMULIN R U-500
MANUF (CMC); Manufacturing (CMC)	SUPPL	139	AP	2013-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	141	AP	2012-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	143	AP	2013-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	144	AP	2013-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	145	AP	2013-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	2014-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	147	AP	2014-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	148	AP	2014-09-23	STANDARD Label for HUMULIN R U-500
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	2014-10-30	STANDARD
LABELING; Labeling	SUPPL	150	AP	2015-02-25	901 REQUIRED Label for HUMULIN R U- 100
MANUF (CMC); Manufacturing (CMC)	SUPPL	151	AP	2015-10-08	STANDARD
LABELING; Labeling	SUPPL	152	AP	2015-12-29	STANDARD Label for HUMULIN R U-500
LABELING; Labeling	SUPPL	153	AP	2016-07-08	STANDARD Label for HUMULIN R U-500
MANUF (CMC); Manufacturing (CMC)	SUPPL	154	AP	2016-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	155	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	168	AP	2018-11-06	STANDARD
LABELING; Labeling	SUPPL	172	AP	2019-08-22	STANDARD
LABELING; Labeling	SUPPL	175	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	176	AP	2019-11-15	901 REQUIRED
LABELING; Labeling	SUPPL	180	AP	2022-06-27	STANDARD

Submissions Property Types

ORIG	1	Null	23
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	61	Null	0
SUPPL	63	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	74	Null	0
SUPPL	75	Null	0
SUPPL	76	Null	0
SUPPL	78	Null	0
SUPPL	80	Null	0
SUPPL	86	Null	0
SUPPL	120	Null	7
SUPPL	124	Null	6
SUPPL	127	Null	0
SUPPL	128	Null	6
SUPPL	132	Null	7
SUPPL	133	Null	7
SUPPL	134	Null	15
SUPPL	135	Null	6
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	15
SUPPL	151	Null	0
SUPPL	152	Null	6
SUPPL	153	Null	7
SUPPL	154	Null	0
SUPPL	155	Null	0
SUPPL	168	Null	7
SUPPL	172	Null	33
SUPPL	175	Null	6
SUPPL	176	Null	6
SUPPL	180	Null	46

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18780
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)