Application 200770

Type: ANDA
Sponsor: STRIDES PHARMA

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
004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	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
A200770-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03
A200770-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03
A200770-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03
A200770-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200770-001	AA
A200770-002	AA
A200770-003	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 5 · 170 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	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-001	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-002	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-003	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-004	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2019-06-25	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 131 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	A200770-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-002	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200770-003	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200770-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200770-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200770-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200770-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200770-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200770-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200770-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200770-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200770-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200770-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200770-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200770-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200770-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200770-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200770-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200770-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200770-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200770-001	AA	1	`301d65b070ca…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Coupler LLC	58773e8c-b6bc-6bc6-e063-6294a90adc26	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Strides Pharma Science Limited	b3d1786d-c3ff-42f1-a09f-37a9c9021e5a	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770 ndc (product): 64380-734 ndc (product): 64380-735 ndc (product): 64380-736 ndc (product): 64380-733
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Proficient Rx LP	dfd60a79-2a30-41e6-b000-a144730099a8	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200770 application number: ANDA200770 ndc (product): 71205-072

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
59556-007	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Inc	ANDA	Current
59556-008	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Inc	ANDA	Current
59556-009	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Inc	ANDA	Current
63739-327	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-327	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-328	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-328	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	McKesson Corporation dba SKY Packaging	ANDA	Current
64380-733	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-733	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-734	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-734	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Shasun Limited	ANDA	Current
64380-734	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-734	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-735	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-735	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Shasun Limited	ANDA	Current
64380-735	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-735	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-736	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-736	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Shasun Limited	ANDA	Current
64380-736	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-736	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Strides Pharma Science Limited	ANDA	Current
70518-1403	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1403	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2091	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2091	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71205-072	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Proficient Rx LP	ANDA	Current
71205-072	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Proficient Rx LP	ANDA	Current
71335-1236	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1236	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Bryant Ranch Prepack	ANDA	Current