Application 090255

Type: ANDA
Sponsor: INVAGEN PHARMS

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 44.

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	Approval date
A090255-001	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-12-15
A090255-002	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	2008-12-15
A090255-003	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	2008-12-15
A090255-004	HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	2008-12-15

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 2 of 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2008-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL		2008-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL		2008-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL		2008-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090255-001	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2008-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-002	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2008-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-003	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET / ORAL	AA	2008-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-004	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET / ORAL	AA	2008-12-15	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-003	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090255-004	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090255-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-003	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090255-004	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090255-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-003	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090255-004	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090255-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090255-004	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090255-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-003	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090255-004	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090255-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-003	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090255-004	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-003	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090255-004	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090255-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-003	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090255-004	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090255-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-003	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090255-004	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090255-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090255-004	AA	1	`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	811831f9-a844-463a-874d-fb8407659f0b	2020-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090255 application number: ANDA090255 ndc (product): 76282-309 ndc (product): 76282-312 ndc (product): 76282-310 ndc (product): 76282-311
HydrALAZINE Hydrochloride	HYDRALAZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	921c8693-84c2-4313-a2a6-ab3be637d554	2016-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090255 application number: ANDA090255 ndc (product): 43353-205

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-205	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-309	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-309	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-309	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-310	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-310	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-310	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-311	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-311	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-311	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-312	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-312	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-312	HydrALAZINE Hydrochloride	HydrALAZINE Hydrochloride	Exelan Pharmaceuticals Inc.	ANDA	Current