Application 200737

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A200737-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07
A200737-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07
A200737-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07
A200737-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200737-001	AA
A200737-002	AA
A200737-003	AA
A200737-004	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	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200737-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200737-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200737-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200737-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2012-12-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A200737-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200737-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200737-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200737-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200737-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200737-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200737-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200737-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200737-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200737-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200737-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200737-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200737-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200737-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200737-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200737-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200737-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200737-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200737-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200737-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200737-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200737-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200737-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200737-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200737-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200737-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200737-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200737-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200737-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200737-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200737-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200737-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200737-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200737-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200737-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200737-004	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200737-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200737-002	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200737-003	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200737-004	AA	1	`6a51e52b5d6a…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydralazine Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Ascend Laboratories, LLC	e7bfec3d-5222-4a26-8f99-6c2a28e14aa6	2017-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200737 application number: ANDA200737 ndc (product): 67877-293 ndc (product): 67877-290 ndc (product): 67877-292 ndc (product): 67877-291

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
67877-290	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-291	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-292	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-293	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Ascend Laboratories, LLC	ANDA	Current