Application 084469

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	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
A084469-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	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	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084469-002	HYDRALAZINE HYDROCHLORIDE	50MG	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 4 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	Hikma Pharmaceuticals USA Inc.	3f5f1204-d289-40e9-be84-a29352f64bfb	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	15b0f03b-b5a2-c49d-e063-6394a90a5b15	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c2638ae6-a210-490f-8389-bbed6a3229c5	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	8224aa3d-b1b9-40df-93fd-a91c6a158898	2024-02-20	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	bc37cf50-b18d-467e-bf67-3270faa8332e	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d5b0165e-9823-470a-8ed0-5c4c8722369d	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4d1594dc-376b-44bd-8c0e-5de731dfb7f9	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	9949407f-e410-7f47-e053-2995a90a7369	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	18dd864f-1e27-4c98-8f21-eaded77a3ed6	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	e6d4b15e-1407-4783-94e4-9971dea68221	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	36499d4b-bcaf-4b49-aa2a-10c3e34550d0	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	4985994c-23ab-4409-bab6-5a17db767f13	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	162a0c00-4db8-4f8d-9686-be2f8449abd8	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	914d5b62-6f9b-4665-8562-689367c36230	2023-12-14	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	d4509f69-e60e-4440-957b-5c2714480335	2023-11-27	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	A-S Medication Solutions	e617023e-b060-4db9-a97e-e2b11a37901e	2023-08-28	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Bryant Ranch Prepack	62475f78-5410-43c2-a11d-54a8363c3ae1	2023-07-25	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	7979c865-737d-d999-e053-2a91aa0abc5e	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d89d981d-64cf-7321-e053-2995a90aab4a	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	dd2cd8a1-7bdd-05e4-e053-2995a90ad366	2023-05-02	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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