Application 090527

Type: ANDA
Sponsor: GLENMARK PHARMS 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 1.

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
A090527-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29
A090527-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29
A090527-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29
A090527-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090527-001	AA
A090527-002	AA
A090527-003	AA
A090527-004	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 · 164 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
2026-02-19 14:30 UTC	2026-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090527-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2009-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2009-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2009-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2009-05-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090527-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090527-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090527-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090527-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090527-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090527-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090527-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090527-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090527-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090527-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090527-004	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090527-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-003	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090527-004	AA	1	`d06236e962d9…`

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	Glenmark Pharmaceuticals Inc., USA	37ba0233-ed75-498a-a067-6220da573653	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090527 application number: ANDA090527 ndc (product): 68462-344 ndc (product): 68462-341 ndc (product): 68462-343 ndc (product): 68462-342

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-944	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0138	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2423	Hydralazine Hydrochloride	Hydralazine Hydrochloride	A-S Medication Solutions	ANDA	Current
53808-0882	Hydralazine Hydrochloride	Hydralazine Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
68462-341	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-342	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-343	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-344	Hydralazine Hydrochloride	Hydralazine Hydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current