Application 084301

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DRALZINE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084301-001	DRALZINE	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084301-001	DRALZINE	25MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 · 95 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	51c293c1-70e7-48c7-8af1-a8b74312ed56	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	6c40d818-77a9-492c-b9b6-d8a0fe8d6736	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	dca82025-a4cd-4856-aa19-bdf091bf8973	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d2d98842-ff32-4a61-94e0-60e06919948f	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	58773e8c-b6bc-6bc6-e063-6294a90adc26	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Cardinal Health 107, LLC	db7500f3-f8a6-46b1-bb64-9727617a9643	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Major Pharmaceuticals	b6ccd35e-f69c-4eef-a456-905e030ae911	2026-07-15	Warnings, Adverse reactions	Name fallback 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 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 generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d61ffa06-8138-4a1d-9530-095a80d9c9ce	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a70d20d6-23f0-477e-915c-678a86782175	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	0d65e146-83e5-427f-ac06-04c0d8e72cea	2026-06-09	Warnings, Adverse reactions	Name fallback 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 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 generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	438479d0-ff61-4008-a0fc-1ee44b97cf7f	2026-05-07	Warnings, Adverse reactions	Name fallback 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 generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Navinta LLC	ae5d85df-11a3-4952-ade2-596d57cdd987	2026-04-21	Warnings, Adverse reactions	Name fallback 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 generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Safecor Health, LLC	66c5eaa4-a51a-464b-98ad-f094f32876dd	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	f3c806a4-b971-421c-bcb9-9979c6d7aaec	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.