NDA 012122

LILLY

FDA Drug Application

Application #012122

Application Sponsors

NDA 012122

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	GLUCAGON	GLUCAGON HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 10MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	GLUCAGON	GLUCAGON HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1960-11-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-05-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1975-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1975-12-31	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	1979-11-27	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	1980-02-21	PRIORITY
EFFICACY; Efficacy	SUPPL	14	AP	1981-06-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-10-09	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1983-07-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-08-02	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1984-08-09	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1984-12-13	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1986-09-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1991-04-03	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1988-01-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1988-09-30	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1988-12-02	PRIORITY
LABELING; Labeling	SUPPL	30	AP	1990-10-04	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1990-10-11	PRIORITY
LABELING; Labeling	SUPPL	32	AP	1990-10-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1991-11-19	PRIORITY
LABELING; Labeling	SUPPL	34	AP	1993-04-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1996-04-19	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1995-12-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1996-12-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1996-11-07	PRIORITY
LABELING; Labeling	SUPPL	39	AP	1997-05-12	PRIORITY
LABELING; Labeling	SUPPL	40	AP	1997-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1998-01-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1997-09-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1998-06-26	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	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	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	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	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12122
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)