Application 020727

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIDIL	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	TABLET;ORAL	37.5MG;20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020727-001	BIDIL	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020727-001	AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL		RLD, RS	2005-06-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020727-001	BIDIL	37.5MG;20MG	TABLET / ORAL	AB	RLD, RS	2005-06-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020727-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020727-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020727-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020727-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020727-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020727-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020727-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020727-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020727-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020727-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020727-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020727-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020727-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020727-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020727-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020727-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020727-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020727-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020727-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020727-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020727-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020727-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020727-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020727-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020727-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020727-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020727-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020727-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020727-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020727-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020727-001	6465463	2020-09-08	U-71	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020727-001	6784177	2020-09-08	U-71	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020727-001	6465463	2020-09-08	U-71	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020727-001	6784177	2020-09-08	U-71	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020727-001	6465463	2020-09-08	U-71	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020727-001	6784177	2020-09-08	U-71	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020727-001	6465463	2020-09-08	U-71	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020727-001	6784177	2020-09-08	U-71	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020727-001	6465463	2020-09-08	U-71	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020727-001	6784177	2020-09-08	U-71	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020727-001	6465463	2020-09-08	U-71	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020727-001	6784177	2020-09-08	U-71	`ea99ee380514…`

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
BiDil	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Azurity Pharmaceuticals, Inc.	e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020727 application number: NDA020727 ndc (product): 24338-010
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Bryant Ranch Prepack	2a6fe05a-fcd4-42d1-bf5d-1d39ac273363	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020727 application number: NDA020727
isosorbide dinitrate and hydralazine hydrochloride	HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE	Wilshire Pharmaceuticals	620a0680-aad0-4923-84be-7393c0cbdcbd	2022-04-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020727 application number: NDA020727 ndc (product): 52536-006

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-010	BiDil	Hydralazine hydrochloride and Isosorbide dinitrate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-010	BiDil	Hydralazine hydrochloride and Isosorbide dinitrate	Arbor Pharmaceuticals, Inc.	NDA	Current
24338-010	BiDil	Hydralazine hydrochloride and Isosorbide dinitrate	Azurity	NDA	Current
24338-010	BiDil	Hydralazine hydrochloride and Isosorbide dinitrate	Arbor Pharmaceuticals, Inc.	NDA	Current
52536-006	isosorbide dinitrate and hydralazine hydrochloride	hydralazine hydrochloride and isosorbide dinitrate	Wilshire Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67571	SUPPL	2021-05-21
67556	SUPPL	2021-05-19
57993	SUPPL	2019-03-14
57977	SUPPL	2019-03-13
13304	SUPPL	2015-04-07
3218	SUPPL	2015-04-03
13303	SUPPL	2013-04-01
25648	SUPPL	2013-03-29
20884	ORIG	2006-06-21
35242	ORIG	2005-06-24
3217	ORIG	2005-06-24