NDA 020928

LILLY

FDA Drug Application

Application #020928

Documents

• Label: 1998-09-11
• Letter: 1998-09-11
• Letter: 2004-02-25
• Label: 2004-04-05
• Review: 1998-09-11
• Label: 2018-04-19
• Letter: 2018-04-20
• Letter: 2018-07-09
• Label: 2018-07-06
• Letter: 2018-12-21
• Letter: 2021-01-27
• Label: 2021-02-03

Application Sponsors

NDA 020928

LILLY

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/VIAL

1

GLUCAGON

GLUCAGON

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-09-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-09-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-01-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-11-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-11-15	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2004-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2013-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2014-03-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2014-08-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2015-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2015-12-18	PRIORITY
LABELING; Labeling	SUPPL	55	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	56	AP	2018-07-06	901 REQUIRED
LABELING; Labeling	SUPPL	57	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	60	AP	2021-01-26	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	55	Null	6
SUPPL	56	Null	7
SUPPL	57	Null	7
SUPPL	60	Null	6

TE Codes

001

Prescription

AP

CDER Filings

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            [ApplNo] => 20928
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)