Application 207107

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	10MG/ML	No	No
002	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/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
A207107-001	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP		2018-06-08
A207107-002	ESMOLOL HYDROCHLORIDE	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP		2018-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207107-001	AP
A207107-002	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 3 · 84 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	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207107-001	ESMOLOL HYDROCHLORIDE	1GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207107-002	ESMOLOL HYDROCHLORIDE	2GM/100ML	INJECTABLE / INJECTION	AP	2018-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207107-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207107-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207107-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207107-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207107-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207107-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207107-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207107-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207107-001	ESMOLOL HYDROCHLORIDE	10MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207107-002	ESMOLOL HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2018-06-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A207107-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207107-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207107-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207107-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207107-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207107-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207107-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207107-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207107-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207107-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207107-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207107-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207107-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207107-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207107-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207107-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207107-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207107-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207107-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207107-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207107-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207107-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207107-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207107-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207107-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207107-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207107-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207107-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207107-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207107-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207107-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207107-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207107-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207107-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207107-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207107-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207107-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207107-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207107-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207107-002	AP	1	`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
esmolol hydrochloride	ESMOLOL HYDROCHLORIDE	Sagent Pharmaceuticals	f12fb0fd-fa05-49fc-b5e3-a2050b816ef2	2023-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207107 application number: ANDA207107 ndc (product): 25021-309 ndc (product): 25021-308

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
25021-308	esmolol hydrochloride	esmolol hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-308	esmolol hydrochloride	esmolol hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-309	esmolol hydrochloride	esmolol hydrochloride	Sagent Pharmaceuticals	ANDA	Current
25021-309	esmolol hydrochloride	esmolol hydrochloride	Sagent Pharmaceuticals	ANDA	Current