Application 215390

Type: NDA
Sponsor: BIOXCEL THERAPEUTICS, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IGALMI	DEXMEDETOMIDINE	FILM;SUBLINGUAL		No	No
002	IGALMI	DEXMEDETOMIDINE	FILM;SUBLINGUAL	180MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N215390-001	IGALMI	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL		RLD, RS	2022-04-05
N215390-002	IGALMI	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL		RLD	2022-04-05

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215390-001	11786508	2037-12-29	U-3698		2023-10-17
N215390-001	11839604	2037-12-29	U-3756		2023-12-12
N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28
N215390-001	11478422	2039-06-26		Drug product	2022-11-22
N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15
N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06
N215390-001	11890272	2040-07-17	U-3756		2024-02-06
N215390-001	11890272	2040-07-17	U-3935		2024-02-06
N215390-001	11998529	2040-07-17	U-3935		2024-06-05
N215390-001	12109196	2040-07-17	U-3935		2024-10-11
N215390-001	11806334	2043-01-12	U-3725		2023-11-07
N215390-001	11998528	2043-01-12	U-3935		2024-06-20
N215390-001	12090140	2043-01-12	U-3986		2024-09-18
N215390-001	12138247	2043-01-12	U-4029		2024-11-13
N215390-001	12364683	2043-01-12	U-4029		2025-08-21
N215390-002	11786508	2037-12-29	U-3698		2023-10-17
N215390-002	11839604	2037-12-29	U-3756		2023-12-12
N215390-002	10792246	2039-06-26	U-3350	Drug product	2022-04-28
N215390-002	11478422	2039-06-26		Drug product	2022-11-22
N215390-002	11497711	2039-06-26	U-3645	Drug product	2022-11-15
N215390-002	11517524	2039-06-26	U-3645	Drug product	2022-12-06
N215390-002	11890272	2040-07-17	U-3756		2024-02-06
N215390-002	11890272	2040-07-17	U-3935		2024-02-06
N215390-002	11998529	2040-07-17	U-3935		2024-06-05
N215390-002	12109196	2040-07-17	U-3935		2024-10-11
N215390-002	11806334	2043-01-12	U-3725		2023-11-07
N215390-002	11998528	2043-01-12	U-3935		2024-06-20
N215390-002	12090140	2043-01-12	U-3986		2024-09-18
N215390-002	12138247	2043-01-12	U-4029		2024-11-13
N215390-002	12364683	2043-01-12	U-4029		2025-08-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215390-001	M-82	2028-11-19
N215390-002	M-82	2028-11-19

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
2026-02-19 14:30 UTC	2026-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD	2022-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 484 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215390-001	11786508	2037-12-29	U-3698		2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11839604	2037-12-29	U-3756		2023-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11478422	2039-06-26		Drug product	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11890272	2040-07-17	U-3935		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11890272	2040-07-17	U-3756		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11998529	2040-07-17	U-3935		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12109196	2040-07-17	U-3935		2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11806334	2043-01-12	U-3725		2023-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11998528	2043-01-12	U-3935		2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12090140	2043-01-12	U-3986		2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12138247	2043-01-12	U-4029		2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12364683	2043-01-12	U-4029		2025-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11786508	2037-12-29	U-3698		2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11839604	2037-12-29	U-3756		2023-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11478422	2039-06-26		Drug product	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11890272	2040-07-17	U-3935		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11890272	2040-07-17	U-3756		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11998529	2040-07-17	U-3935		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12109196	2040-07-17	U-3935		2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11806334	2043-01-12	U-3725		2023-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11998528	2043-01-12	U-3935		2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12090140	2043-01-12	U-3986		2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12138247	2043-01-12	U-4029		2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12364683	2043-01-12	U-4029		2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11786508	2037-12-29	U-3698		2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11839604	2037-12-29	U-3756		2023-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11478422	2039-06-26		Drug product	2022-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11890272	2040-07-17	U-3935		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11890272	2040-07-17	U-3756		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11998529	2040-07-17	U-3935		2024-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	12109196	2040-07-17	U-3935		2024-10-11	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215390-001	M-82	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	M-82	2028-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	NP	2025-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-002	NP	2025-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215390-001	NP	2025-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215390-002	NP	2025-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-001	NP	2025-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-002	NP	2025-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-001	NP	2025-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-002	NP	2025-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-001	NP	2025-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-002	NP	2025-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-001	NP	2025-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-002	NP	2025-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-001	NP	2025-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-002	NP	2025-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-001	NP	2025-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-002	NP	2025-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215390-001	NP	2025-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215390-002	NP	2025-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-001	NP	2025-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-002	NP	2025-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-001	NP	2025-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-002	NP	2025-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-001	NP	2025-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-002	NP	2025-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215390-001	NP	2025-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215390-002	NP	2025-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-001	NP	2025-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-002	NP	2025-04-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-001	NP	2025-04-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-002	NP	2025-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215390-001	NP	2025-04-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215390-002	NP	2025-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215390-001	NP	2025-04-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215390-002	NP	2025-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-001	NP	2025-04-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-002	NP	2025-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-001	NP	2025-04-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-002	NP	2025-04-05	`9b2671bbb829…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine	DEXMEDETOMIDINE	Avenacy Inc.	eee6145b-d83f-4596-92d3-733934d8a3a4	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
DEXMEDETOMIDINE	DEXMEDETOMIDINE	Meitheal Pharmaceuticals Inc.	8fa36783-b94d-4084-8c41-40ee64192074	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Eugia US LLC	8c162541-986b-4b30-866c-b2631ba2c975	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Piramal Critical Care Inc	c116d83f-35da-19ca-e053-2a95a90a017d	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Piramal Critical Care Inc	b93a71ed-0f9e-1ff9-e053-2995a90a789d	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	WG Critical Care, LLC	0d2710f2-ee47-4114-ab5c-8dca74cdcb8d	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Gland Pharma Limited	714cc0d2-8a4c-40c0-8ef0-dcfde4c46989	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Mylan Institutional LLC	ebdfe2e8-30ca-4f18-935a-41bcbbce4937	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	ProPharma Distribution	42cbeadf-fea3-d2ae-e063-6394a90ad549	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
DEXMEDETOMIDINE	DEXMEDETOMIDINE	ProPharma Distribution	42dab90e-68c1-bed1-e063-6294a90a4b0c	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Accord Healthcare Inc.	2b9881f0-4a66-660f-e054-00144ff88e88	2025-02-11	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE
Dexmedetomidine	DEXMEDETOMIDINE	Medical Purchasing Solutions, LLC	12ef0602-bf07-6ddd-e063-6294a90a23c3	2024-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXMEDETOMIDINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81092-1120	IGALMI	DEXMEDETOMIDINE	BioXcel Therapeutics, Inc.	NDA	Current
81092-1120	IGALMI	DEXMEDETOMIDINE	BioXcel Therapeutics, Inc.	NDA	Current
81092-1180	IGALMI	DEXMEDETOMIDINE	BioXcel Therapeutics, Inc.	NDA	Current
81092-1180	IGALMI	DEXMEDETOMIDINE	BioXcel Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84243	SUPPL	2025-11-21
84239	SUPPL	2025-11-20
73264	ORIG	2023-01-23
73263	ORIG	2023-01-23
72464	SUPPL	2022-10-25
70739	ORIG	2022-04-11
70711	ORIG	2022-04-06