Application 214231

Type: NDA
Sponsor: ZEALAND PHARMA AS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEGALOGUE	DASIGLUCAGON	INJECTABLE;INJECTION	0.6MG/0.6ML	Yes	No
002	ZEGALOGUE (AUTOINJECTOR)	DASIGLUCAGON HYDROCHLORIDE	SOLUTION;SUBCUTANEOUS	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	Yes	Yes

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
N214231-001	ZEGALOGUE	DASIGLUCAGON HYDROCHLORIDE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD	2021-03-22
N214231-002	ZEGALOGUE (AUTOINJECTOR)	DASIGLUCAGON HYDROCHLORIDE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD	2021-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214231-001	11795204	2034-01-06	U-3752		2023-11-24
N214231-001	10442847	2035-03-22		Drug substance, Drug product	2021-04-21
N214231-002	11795204	2034-01-06	U-3752		2023-11-24
N214231-002	10442847	2035-03-22		Drug substance, Drug product	2021-04-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214231-001	NCE	2026-03-22
N214231-001	NPP	2029-06-18
N214231-002	NCE	2026-03-22
N214231-002	NPP	2029-06-18

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 · 70 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	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD	2021-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD	2021-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214231-001	ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214231-002	ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-03-22	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-001	10442847	2035-03-22		Drug substance, Drug product	2021-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	10442847	2035-03-22		Drug substance, Drug product	2021-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	11795204	2034-01-06	U-3752		2023-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	11795204	2034-01-06	U-3752		2023-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	10442847	2035-02-03		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214231-001	NCE	2026-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-001	NPP	2029-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	NCE	2026-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214231-002	NPP	2029-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214231-001	NCE	2026-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214231-002	NCE	2026-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-001	NCE	2026-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214231-002	NCE	2026-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214231-001	NCE	2026-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214231-002	NCE	2026-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-001	NCE	2026-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214231-002	NCE	2026-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-001	NCE	2026-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214231-002	NCE	2026-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-001	NCE	2026-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214231-002	NCE	2026-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-001	NCE	2026-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214231-002	NCE	2026-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-001	NCE	2026-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214231-002	NCE	2026-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-001	NCE	2026-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214231-002	NCE	2026-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214231-001	NCE	2026-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214231-002	NCE	2026-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-001	NCE	2026-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214231-002	NCE	2026-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-001	NCE	2026-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214231-002	NCE	2026-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-001	NCE	2026-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214231-002	NCE	2026-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214231-001	NCE	2026-03-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214231-002	NCE	2026-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-001	NCE	2026-03-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214231-002	NCE	2026-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214231-001	NCE	2026-03-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214231-002	NCE	2026-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214231-001	NCE	2026-03-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214231-002	NCE	2026-03-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214231-001	NCE	2026-03-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214231-002	NCE	2026-03-22	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zegalogue	DASIGLUCAGON	Novo Nordisk	14704879-872c-4967-8779-04a3bbdfb4e6	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214231 application number: NDA214231

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80644-0012	Zegalogue	dasiglucagon	Zealand Pharma A/S	NDA	Current
80644-0012	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0012	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0012	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0012	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0013	Zegalogue	dasiglucagon	Zealand Pharma A/S	NDA	Current
80644-0013	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0013	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0013	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current
80644-0013	Zegalogue	dasiglucagon	Zealand Pharma US, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67117	ORIG	2021-04-19
66840	ORIG	2021-03-23
66833	ORIG	2021-03-22