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 2 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	Coupler LLC	4aa1b3e8-9389-fe2c-e063-6294a90a7fb9	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	89afc8ef-27c4-489a-81de-3f8f65f6bbb8	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Hydralazine Hydrochloride generic name: HYDRALAZINE HYDROCHLORIDE
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	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	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	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

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