Application 088847

Type: ANDA
Sponsor: CHARTWELL RX

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
A088847-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL			1985-02-26

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088847-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	1985-02-26	`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 3 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	Henry Schein, Inc.	4d1f55aa-e924-4540-ae9f-bd7362a82f33	2025-05-20	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	a79ddc89-546b-4808-879d-c0f592141636	2025-03-31	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	90c18c55-3045-4a10-a2bb-012e4a5e1564	2025-03-25	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	5da36930-d3da-4b5c-9e22-2b141bc01a9c	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Baxter Healthcare Corporation	f1a10203-f027-4f9c-8dd6-907c6db24d47	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2e9688ef-781c-aead-e063-6294a90a7bca	2025-02-20	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2df51a19-a39a-0ec8-e063-6394a90a147c	2025-02-12	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	775e99c4-e18d-4648-a0e3-8709950249ff	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	94530e4d-b1c0-6171-e053-2a95a90a05fa	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	7ae650f7-a481-4637-a9a2-9bda43a5a288	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a862321d-ebc1-7676-e053-2995a90a5861	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	ff2c4d1e-33ee-40d7-955b-d736f0559f39	2024-12-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	10f3e76e-9bba-4151-89fb-90d823a0a68c	2024-11-08	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Health Packaging	2e82655e-8435-46fa-b734-8e7c6e803453	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	f9f56326-6d72-47d3-89ac-3625b8a6d713	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f07abdec-6d94-45b6-be1b-10a898ea28c2	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	8ade1ffe-3738-4aa1-b9c7-59f7290600b9	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3b61d1b0-c699-67a8-e054-00144ff88e88	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4b7d3378-86f8-0a5f-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE

Application 088847

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#