Application 084922

Type: ANDA
Sponsor: IMPAX LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	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
A084922-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084922-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`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 2 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	Strides Pharma Science Limited	b3d1786d-c3ff-42f1-a09f-37a9c9021e5a	2026-02-02	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.	a04eefaf-ba3c-448d-8ece-4aa9ab2e3508	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e9450e82-329f-4fd8-a0b3-3e8e22715965	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ab1c6f37-3b64-23fb-e053-2995a90a932f	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Northwind Health Company, LLC	ada28f78-e933-7acf-e053-2995a90ae316	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	bf1b7c2f-535c-45bb-928a-65606d87685e	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Chartwell RX, LLC	0c7f9bd0-6c0a-4521-b77a-3582faa96874	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	7253aaa0-e272-499f-9bfa-304e9556a8fb	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	f16f1d87-f9e6-4555-9baf-26ff17cb1d28	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	f34904dc-c945-4de4-8594-34e4f4ac1983	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Eugia US LLC	e08d8b6c-a184-4dd5-84ef-bac90e4b1c33	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	336b11da-e592-4386-921f-3c136d754f2a	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	41c019e3-7b07-5f12-e063-6294a90a5365	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d2d98842-ff32-4a61-94e0-60e06919948f	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	3f8fb1fc-ffef-4f94-e063-6294a90a2b82	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Mylan Institutional Inc.	493a8b7e-5bb1-4db2-91a7-77ed87864131	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ProPharma Distribution	3855c3da-ff25-8301-e063-6294a90a22b3	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: hydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	024ac6b8-5ce0-4435-9b11-b1806c511d7b	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	51c293c1-70e7-48c7-8af1-a8b74312ed56	2025-06-19	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE

Application 084922

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#