Application 209307

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No
002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	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
A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2020-06-03
A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP		2020-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209307-001	AP
A209307-002	AP

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209307-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209307-002	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	INJECTABLE / INJECTION	AP	2020-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209307-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209307-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209307-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209307-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209307-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209307-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209307-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209307-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209307-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209307-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209307-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209307-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209307-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209307-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209307-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209307-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209307-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209307-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209307-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209307-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209307-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209307-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209307-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209307-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209307-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209307-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209307-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209307-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209307-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209307-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209307-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209307-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209307-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209307-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209307-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209307-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209307-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209307-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209307-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209307-002	AP	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Piramal Critical Care Inc	c958aeb4-69ce-c3e2-e053-2a95a90a6d8d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209307 application number: ANDA209307 ndc (product): 66794-234 ndc (product): 66794-235
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Gland Pharma Limited	f307de7e-a9ab-4734-abb7-66b4e112bc51	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209307 application number: ANDA209307 ndc (product): 68083-239 ndc (product): 68083-238
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Sagent Pharmaceuticals	65885aef-faaf-4dec-a180-9a657f738bbc	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209307 application number: ANDA209307
DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	d174c19d-56f1-4ef4-087c-23c26db8e40b	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209307 application number: ANDA209307 ndc (product): 43598-976 ndc (product): 43598-975

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43598-975	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	ANDA	Current
43598-975	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	ANDA	Current
43598-976	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	ANDA	Current
43598-976	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	Dr.Reddy's Laboratories Inc	ANDA	Current
66794-234	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-234	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-234	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-234	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-234	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-235	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-235	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-235	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-235	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
66794-235	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Piramal Critical Care Inc	ANDA	Current
68083-238	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-239	Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	Gland Pharma Limited	ANDA	Current