Application 203845

Type: ANDA
Sponsor: CADILA PHARMS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203845-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18
A203845-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18
A203845-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203845-001	AA
A203845-002	AA
A203845-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2014-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203845-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2014-09-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203845-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203845-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203845-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203845-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203845-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203845-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203845-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203845-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203845-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203845-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203845-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203845-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203845-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203845-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203845-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203845-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203845-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203845-001	AA	1	`1e350fbaab3a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	2df51a19-a39a-0ec8-e063-6394a90a147c	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Modavar Pharmaceuticals LLC	a456bc34-0c79-44f4-9119-50028a978f5f	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845 ndc (product): 72241-005 ndc (product): 72241-006 ndc (product): 72241-004
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	Cadila Pharmaceuticals Limited	3a7562a8-2f67-4411-ac4a-ab7924193e82	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845 ndc (product): 71209-017 ndc (product): 71209-018 ndc (product): 71209-016
Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	1fd8cf42-66ae-4af5-a5ae-7c9679a0e532	2022-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203845 application number: ANDA203845 ndc (product): 75834-126 ndc (product): 75834-128 ndc (product): 75834-127

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1581	Hydralazine	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-1581	Hydralazine	HYDRALAZINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71209-016	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-016	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-016	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-016	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-017	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-017	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-017	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-017	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-018	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-018	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-018	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
71209-018	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Cadila Pharmaceuticals Limited	ANDA	Current
72241-004	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Modavar Pharmaceuticals LLC	ANDA	Current
72241-005	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Modavar Pharmaceuticals LLC	ANDA	Current
72241-006	HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride	Modavar Pharmaceuticals LLC	ANDA	Current
75834-126	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-126	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-126	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-127	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-127	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-127	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-128	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-128	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-128	Hydralazine	HYDRALAZINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	ANDA	Current