Application 206628

Type: NDA
Sponsor: HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	Yes	No
002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	Yes	Yes
003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	Yes	No
004	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21
N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21
N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22
N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N206628-001	AP
N206628-002	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206628-003	9649296	2036-04-20	Drug product	2018-06-26
N206628-003	9717796	2036-04-20	Drug product	2018-06-26
N206628-004	9649296	2036-04-20	Drug product	2018-06-26
N206628-004	9717796	2036-04-20	Drug product	2018-06-26

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2015-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2015-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	SOLUTION / INTRAVENOUS		RLD	2018-06-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N206628-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206628-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-002	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206628-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206628-002	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206628-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206628-002	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	9649296	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-003	9717796	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	9649296	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206628-004	9717796	2036-04-20	Drug product	2018-06-26	`d8e5a09893c0…`

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
Dexmedetomidine	DEXMEDETOMIDINE	WG Critical Care, LLC	0d2710f2-ee47-4114-ab5c-8dca74cdcb8d	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206628 application number: NDA206628 ndc (product): 44567-603 ndc (product): 44567-600 ndc (product): 44567-601 ndc (product): 44567-602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-600	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-601	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-602	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current
44567-603	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	WG Critical Care, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85835	SUPPL	2026-05-05
85823	SUPPL	2026-05-04
77928	SUPPL	2024-03-25
77915	SUPPL	2024-03-22
75286	SUPPL	2023-08-25
75269	SUPPL	2023-08-23
45380	SUPPL	2016-09-21
45352	SUPPL	2016-09-21
43526	ORIG	2016-05-27
19729	ORIG	2015-10-26
10589	ORIG	2015-10-23