BLA 019717

LILLY

FDA Drug Application

Application #019717

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

Application Sponsors

BLA 019717

LILLY

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	INJECTABLE;INJECTION	30 UNITS/ML;70 UNITS/ML	0	HUMULIN 70/30	INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
002	INJECTABLE;INJECTION	30 UNITS/ML;70 UNITS/ML	0	HUMULIN 70/30 PEN	INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1989-04-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	1990-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-09-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	1991-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-01-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	1992-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-02-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	1995-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-03-09	STANDARD
LABELING; Labeling	SUPPL	13	AP	1995-09-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	1995-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1996-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-07-26	STANDARD
LABELING; Labeling	SUPPL	20	AP	1996-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1997-01-28	STANDARD
LABELING; Labeling	SUPPL	23	AP	1997-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1998-02-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-02-25	STANDARD
LABELING; Labeling	SUPPL	30	AP	2002-11-01	STANDARD
LABELING; Labeling	SUPPL	32	AP	2003-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2002-04-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2002-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-03-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-03-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2002-03-29	STANDARD
LABELING; Labeling	SUPPL	41	AP	2002-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2002-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2002-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2002-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2002-09-25	STANDARD
LABELING; Labeling	SUPPL	50	AP	2003-11-17	STANDARD
LABELING; Labeling	SUPPL	52	AP	2003-06-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2003-11-19	STANDARD
LABELING; Labeling	SUPPL	58	AP	2004-04-23	STANDARD
LABELING; Labeling	SUPPL	60	AP	2004-11-10	STANDARD
LABELING; Labeling	SUPPL	65	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	68	AP	2007-09-07	STANDARD
LABELING; Labeling	SUPPL	69	AP	2007-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	2009-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2012-03-21	STANDARD
LABELING; Labeling	SUPPL	94	AP	2010-06-10	UNKNOWN
LABELING; Labeling	SUPPL	98	AP	2013-11-07	UNKNOWN
LABELING; Labeling	SUPPL	99	AP	2013-03-09	STANDARD
LABELING; Labeling	SUPPL	101	AP	2013-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	2013-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	107	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	108	AP	2013-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	111	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	112	AP	2013-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	113	AP	2013-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	115	AP	2013-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	116	AP	2013-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	118	AP	2014-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	119	AP	2014-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	120	AP	2014-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	121	AP	2014-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	122	AP	2014-04-11	STANDARD
LABELING; Labeling	SUPPL	123	AP	2013-12-09	STANDARD
LABELING; Labeling	SUPPL	124	AP	2014-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	126	AP	2014-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	129	AP	2014-09-12	STANDARD
LABELING; Labeling	SUPPL	133	AP	2015-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	135	AP	2015-03-12	STANDARD
LABELING; Labeling	SUPPL	146	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	161	AP	2018-11-06	STANDARD
LABELING; Labeling	SUPPL	165	AP	2019-08-22	STANDARD
LABELING; Labeling	SUPPL	168	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	169	AP	2019-11-15	901 REQUIRED
LABELING; Labeling	SUPPL	174	AP	2022-06-27	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	29	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	54	Null	0
SUPPL	87	Null	0
SUPPL	93	Null	0
SUPPL	94	Null	6
SUPPL	98	Null	6
SUPPL	99	Null	7
SUPPL	101	Null	7
SUPPL	105	Null	0
SUPPL	107	Null	0
SUPPL	108	Null	0
SUPPL	111	Null	0
SUPPL	112	Null	0
SUPPL	113	Null	0
SUPPL	115	Null	0
SUPPL	116	Null	0
SUPPL	118	Null	0
SUPPL	119	Null	0
SUPPL	120	Null	0
SUPPL	121	Null	0
SUPPL	122	Null	0
SUPPL	123	Null	6
SUPPL	124	Null	6
SUPPL	126	Null	0
SUPPL	129	Null	0
SUPPL	133	Null	15
SUPPL	135	Null	15
SUPPL	146	Null	15
SUPPL	161	Null	7
SUPPL	165	Null	15
SUPPL	168	Null	7
SUPPL	169	Null	7
SUPPL	174	Null	7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19717
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)