Application 207707

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/ML	No	No
002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	80MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207707-001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP		2018-04-11
A207707-002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP		2018-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207707-001	AP
A207707-002	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 · 82 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	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207707-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207707-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207707-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207707-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207707-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207707-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207707-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207707-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207707-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207707-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207707-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207707-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207707-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207707-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207707-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207707-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207707-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207707-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	38431050-007e-41b2-e063-6394a90a1d64	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	0e499952-46c7-4172-8c70-186312e240a3	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707 ndc (product): 0143-9253 ndc (product): 0143-9254 ndc (product): 0143-9252 ndc (product): 0143-9255
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c901b461-4f98-da0a-e053-2a95a90a106e	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707 ndc (product): 51662-1489
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c6c8539b-0da9-2d97-e053-2a95a90a3aa8	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707 ndc (product): 51662-1490
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	093312af-6eef-1f4b-e063-6294a90a155d	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9252	Dopamine Hydrochloride	Dopamine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9252	Dopamine Hydrochloride	Dopamine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9253	Dopamine Hydrochloride	Dopamine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9253	Dopamine Hydrochloride	Dopamine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9254	Dopamine Hydrochloride	Dopamine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9254	Dopamine Hydrochloride	Dopamine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9255	Dopamine Hydrochloride	Dopamine Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9255	Dopamine Hydrochloride	Dopamine Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
51662-1489	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1489	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1490	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current