Application 205236

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

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	TE codes	Approval date
A205236-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26
A205236-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26
A205236-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26
A205236-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205236-001	AA
A205236-002	AA
A205236-003	AA
A205236-004	AA

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2017-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2017-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2017-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2017-05-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205236-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-003	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205236-004	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205236-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205236-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205236-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205236-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205236-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205236-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205236-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205236-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205236-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205236-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205236-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205236-004	AA	1	`5bbf6a4d5a75…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	500b7f76-5f4e-4e7d-85c3-18b9f66d7504	2021-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205236 application number: ANDA205236 ndc (product): 50228-184 ndc (product): 50228-182 ndc (product): 50228-185 ndc (product): 50228-183

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 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-182	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-182	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-182	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-183	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-183	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-183	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-184	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-184	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-184	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-185	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-185	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-185	Hydralazine Hydrochloride	Hydralazine Hydrochloride	ScieGen Pharmaceuticals, Inc.	ANDA	Current
63629-8493	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8493	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8494	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8494	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8495	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8495	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8496	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8496	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8497	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8497	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-549	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-561	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-562	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
77771-182	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-183	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-184	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-185	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Radha Pharmaceuticals, Inc.	ANDA	Current