BLA 021018

LILLY

FDA Drug Application

Application #021018

Documents

• Other: 2020-03-23
• Other: 2020-03-23
• 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

Application Sponsors

BLA 021018

LILLY

Marketing Status

• Prescription: 001
• Prescription: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INJECTION	50 UNITS/ML;50 UNITS/ML	0	HUMALOG MIX 50/50	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
002	INJECTABLE;INJECTION	50 UNITS/ML;50 UNITS/ML	0	HUMALOG MIX 50/50 KWIKPEN	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
003	INJECTABLE;INJECTION	50 UNITS/ML;50 UNITS/ML	0	HUMALOG MIX 50/50 PEN	INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination	ORIG	1	AP	1999-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-10-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2003-11-19	STANDARD
LABELING; Labeling	SUPPL	23	AP	2007-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2007-09-06	STANDARD
LABELING; Labeling	SUPPL	35	AP	2008-05-01	STANDARD
LABELING; Labeling	SUPPL	41	AP	2007-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2009-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2012-03-21	STANDARD
LABELING; Labeling	SUPPL	67	AP	2013-03-11	STANDARD
LABELING; Labeling	SUPPL	69	AP	2011-10-30	STANDARD
LABELING; Labeling	SUPPL	70	AP	2018-09-26	STANDARD
LABELING; Labeling	SUPPL	74	AP	2018-09-26	STANDARD
LABELING; Labeling	SUPPL	77	AP	2013-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	81	AP	2013-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	2013-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	2013-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	2014-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	2014-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	92	AP	2014-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2014-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	2014-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	2014-09-12	STANDARD
LABELING; Labeling	SUPPL	100	AP	2015-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	111	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	127	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	129	AP	2019-11-15	901 REQUIRED

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	11	Null	0
SUPPL	34	Null	0
SUPPL	49	Null	0
SUPPL	56	Null	0
SUPPL	67	Null	15
SUPPL	69	Null	6
SUPPL	70	Null	6
SUPPL	74	Null	6
SUPPL	77	Null	6
SUPPL	81	Null	0
SUPPL	85	Null	0
SUPPL	88	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	92	Null	0
SUPPL	93	Null	0
SUPPL	95	Null	0
SUPPL	96	Null	0
SUPPL	100	Null	6
SUPPL	111	Null	7
SUPPL	127	Null	15
SUPPL	129	Null	15

CDER Filings

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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

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