Application 203110

Type: ANDA
Sponsor: XGEN PHARMS

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
A203110-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION			2015-06-29

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	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2015-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2015-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION		2015-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203110-001	HYDRALAZINE HYDROCHLORIDE	20MG/ML	INJECTABLE / INJECTION	AP	2015-06-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203110-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203110-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203110-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203110-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203110-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203110-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203110-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203110-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203110-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203110-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203110-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203110-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203110-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203110-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203110-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203110-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203110-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203110-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203110-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203110-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203110-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203110-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203110-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203110-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203110-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203110-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203110-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203110-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203110-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203110-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203110-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203110-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203110-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203110-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203110-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203110-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203110-001	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 5 · 99 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Major Pharmaceuticals	b6ccd35e-f69c-4eef-a456-905e030ae911	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	1275dd50-d97f-2e8f-e063-6394a90a4a67	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	8b7e88ef-5edd-40df-8e43-e3f29970be58	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d61ffa06-8138-4a1d-9530-095a80d9c9ce	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a70d20d6-23f0-477e-915c-678a86782175	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	0d65e146-83e5-427f-ac06-04c0d8e72cea	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4671cefa-4468-4116-ba40-3d3b0f581ea1	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	43ce0ecb-6d62-44bf-8539-823ae03eb9f4	2026-06-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	a1066707-2391-4918-8ded-600c017fde48	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	438479d0-ff61-4008-a0fc-1ee44b97cf7f	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	f0db9c3c-d841-46f9-8409-9ffca83d7a97	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Navinta LLC	ae5d85df-11a3-4952-ade2-596d57cdd987	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: hydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	db138daf-2d2d-4730-a621-a1bd209d5b9f	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	669532c9-ba15-4f4b-95a8-13782deb3521	2026-04-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6c40d818-77a9-492c-b9b6-d8a0fe8d6736	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	f3c806a4-b971-421c-bcb9-9979c6d7aaec	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	4aa1b3e8-9389-fe2c-e063-6294a90a7fb9	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE

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
39822-0500	Hydralazine Hydrochloride	Hydralazine Hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
39822-0500	Hydralazine Hydrochloride	Hydralazine Hydrochloride	XGen Pharmaceuticals DJB, Inc.	ANDA	Current
39822-0500	Hydralazine Hydrochloride	Hydralazine Hydrochloride	X-GEN Pharmaceuticals, Inc.	ANDA	Current
71872-7050	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10166	ORIG	2015-07-08