Application 202126

Type: ANDA
Sponsor: SUN PHARM INDS INC

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/2ML (EQ 100MCG BASE/ML)	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP		2015-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202126-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202126-001	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	INJECTABLE / INJECTION	AP	2015-08-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202126-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202126-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202126-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202126-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202126-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202126-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202126-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202126-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202126-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202126-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202126-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202126-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202126-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202126-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202126-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202126-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202126-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202126-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202126-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202126-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202126-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202126-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202126-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202126-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202126-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202126-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202126-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202126-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202126-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202126-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202126-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202126-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202126-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202126-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202126-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202126-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202126-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202126-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202126-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202126-001	AP	1	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmedetomidine	DEXMEDETOMIDINE	Piramal Critical Care Inc	c116d83f-35da-19ca-e053-2a95a90a017d	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126 ndc (product): 66794-233
Dexmedetomidine	DEXMEDETOMIDINE	Piramal Critical Care Inc	b93a71ed-0f9e-1ff9-e053-2995a90a789d	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126 ndc (product): 66794-230
Dexmedetomidine	DEXMEDETOMIDINE	Gland Pharma Limited	714cc0d2-8a4c-40c0-8ef0-dcfde4c46989	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126
Dexmedetomidine	DEXMEDETOMIDINE	ProPharma Distribution	42cbeadf-fea3-d2ae-e063-6394a90ad549	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126
Dexmedetomidine	DEXMEDETOMIDINE	Medical Purchasing Solutions, LLC	12ef0602-bf07-6ddd-e063-6294a90a23c3	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	6937235f-ea25-4950-e053-2991aa0a9b74	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126 ndc (product): 71872-7122
Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Sun Pharmaceuticals Industries, Inc.	4fe788bc-4ad1-4b32-83d3-dcbfcd8429aa	2018-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202126 application number: ANDA202126 ndc (product): 57664-596

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
57664-596	Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Sun Pharmaceuticals Industries, Inc.	ANDA	Current
66794-230	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-230	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-230	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-233	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-233	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-233	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
66794-233	Dexmedetomidine	Dexmedetomidine	Piramal Critical Care Inc	ANDA	Current
71872-7122	Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7122	Dexmedetomidine Hydrochloride	DEXMEDETOMIDINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	ANDA	Current