Application 209251

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A209251-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09
A209251-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09
A209251-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09
A209251-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209251-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2018-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209251-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209251-004	AA	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209251-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209251-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209251-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209251-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209251-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209251-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209251-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209251-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209251-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209251-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209251-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209251-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209251-004	AA	1	`ea99ee380514…`

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 5 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	Cadila Pharmaceuticals Limited	3a7562a8-2f67-4411-ac4a-ab7924193e82	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: HYDRALAZINE HYDROCHLORIDE generic name: HYDRALAZINE HYDROCHLORIDE
hydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c3797028-c625-4f70-ae69-8a5f6f23f1b8	2022-08-09	Warnings, Adverse reactions	Name fallback brand name: hydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	8223c44a-73a9-4da5-a468-d1d8bdb0bbd6	2022-05-18	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Radha Pharmaceuticals, Inc.	149fa857-30ad-451d-b6e2-0000483ccc97	2021-03-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	500b7f76-5f4e-4e7d-85c3-18b9f66d7504	2021-03-04	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	811831f9-a844-463a-874d-fb8407659f0b	2020-09-04	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	63f388e0-9f3d-4902-990c-9a105aa098ad	2020-09-01	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	dfd60a79-2a30-41e6-b000-a144730099a8	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	48cf71dd-19dc-4239-9117-ebcf9731a45d	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	American Regent, Inc.	17210abc-58f6-442e-8ff2-7971333c82f6	2019-05-06	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Ascend Laboratories, LLC	e7bfec3d-5222-4a26-8f99-6c2a28e14aa6	2017-12-28	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	bfbd5960-ae6b-46f5-adfa-e330d7a21dfa	2017-12-21	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	921c8693-84c2-4313-a2a6-ab3be637d554	2016-07-14	Warnings, Adverse reactions	Name fallback brand name: HydrALAZINE Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d9892176-d4a6-4edb-92b9-5f56243f3d22	2016-06-13	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	ddbbdb09-3202-42d7-bbb0-08331dde2f54	2016-02-29	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.

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
55801-113	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Appco Pharma LLC	ANDA	Current
55801-114	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Appco Pharma LLC	ANDA	Current
55801-115	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Appco Pharma LLC	ANDA	Current
55801-116	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Appco Pharma LLC	ANDA	Current