Application 040136

Type: ANDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/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
A040136-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP		1997-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040136-001	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	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		1997-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040136-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	1997-06-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040136-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040136-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040136-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040136-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040136-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040136-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040136-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040136-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040136-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040136-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040136-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040136-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040136-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040136-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040136-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040136-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040136-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040136-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040136-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040136-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040136-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040136-001	AP	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040136-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040136-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040136-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040136-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040136-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040136-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040136-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040136-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040136-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040136-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040136-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040136-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040136-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040136-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Civica, Inc.	ffa483a4-de2a-4d42-ad27-afacd37f28e4	2024-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136 ndc (product): 72572-265
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Regent, Inc.	17210abc-58f6-442e-8ff2-7971333c82f6	2019-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040136 application number: ANDA040136 ndc (product): 0517-0901

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0517-0901	Hydralazine Hydrochloride	Hydralazine Hydrochloride	American Regent, Inc.	ANDA	Current
72572-265	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
29893	SUPPL	2014-02-28
17749	SUPPL	2014-02-28
42583	ORIG	2003-07-30