Application 020918

Type: NDA
Sponsor: NOVO NORDISK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLUCAGEN	GLUCAGON HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	Yes	Yes
002	GLUCAGEN	GLUCAGON HYDROCHLORIDE	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020918-001	GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS		RLD	1998-06-22
N020918-002	GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS		RLD	1998-06-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD	1998-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD	1998-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS	RLD, RS	1998-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020918-002	GLUCAGEN	EQ 1MG BASE/VIAL	POWDER / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	RLD, RS	1998-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020918-001	GLUCAGEN	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	1998-06-22	`c0c555d07b60…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-7065	GlucaGen HypoKit	glucagon hydrochloride	Novo Nordisk	NDA	Current
0169-7065	GlucaGen HypoKit	glucagon hydrochloride	Novo Nordisk	NDA	Current
0169-7065	GlucaGen HypoKit	glucagon hydrochloride	Novo Nordisk	NDA	Current
0169-7065	GlucaGen HypoKit	glucagon hydrochloride	Novo Nordisk	NDA	Current
0169-7065	GlucaGen HypoKit	glucagon hydrochloride	Novo Nordisk	NDA	Current
0597-0053	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0053	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0053	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0053	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0053	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0260	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0260	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0260	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0260	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0260	GlucaGen	glucagon hydrochloride	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68169	SUPPL	2021-07-23
68144	SUPPL	2021-07-22
66764	SUPPL	2021-03-12
66761	SUPPL	2021-03-12
64589	SUPPL	2020-09-17
54866	SUPPL	2018-07-09
53763	SUPPL	2018-04-20
53737	SUPPL	2018-04-19
13735	SUPPL	2015-12-15
3746	SUPPL	2015-12-15
3745	SUPPL	2014-03-19
3744	SUPPL	2013-04-30
26190	SUPPL	2012-01-17
13734	SUPPL	2012-01-06
35640	SUPPL	2010-12-22
3743	SUPPL	2010-12-21
41811	SUPPL	2007-07-20
41810	SUPPL	2007-07-20
35639	SUPPL	2005-11-18
26189	SUPPL	2005-11-18
41809	ORIG	2005-06-23
13733	SUPPL	2004-12-29
3742	SUPPL	2004-12-29
35638	SUPPL	2004-04-05
26188	SUPPL	2004-03-02
3741	SUPPL	2002-07-11
26187	ORIG	1998-06-22
13732	ORIG	1998-06-22