Application 088088

Type: ANDA
Sponsor: HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	20MG	No	No
002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	10MG	No	No
003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	5MG	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
A088088-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02
A088088-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29
A088088-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088088-001	AB
A088088-002	AB
A088088-003	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 · 52 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	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-003	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	1987-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088088-001	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	1987-11-02	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A088088-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088088-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088088-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088088-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088088-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088088-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088088-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088088-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088088-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088088-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088088-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088088-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088088-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088088-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088088-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088088-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088088-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088088-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088088-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088088-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088088-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088088-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088088-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088088-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088088-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088088-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088088-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088088-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088088-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088088-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088088-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088088-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088088-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088088-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088088-001	AB	1	`a72a2bbeb626…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Cardinal Health 107, LLC	5f585259-59ed-4648-b562-164f3746c821	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 55154-7991
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Major Pharmaceuticals	6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 0904-6620
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Golden State Medical Supply, Inc.	7f860fbd-f130-4652-e053-2991aa0a402e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 51407-149
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Hikma Pharmaceuticals USA Inc.	f0b9b320-0bf8-4342-b654-135ccb6755c2	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 0143-1772
Isosorbide	ISOSORBIDE DINITRATE	BluePoint Laboratories	9498fa14-1614-4a8e-b872-41c11745b01e	2018-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088088 application number: ANDA088088 ndc (product): 68001-375

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1772	Isosorbide Dinitrate	Isosorbide Dinitrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-1772	Isosorbide Dinitrate	Isosorbide Dinitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1772	Isosorbide Dinitrate	Isosorbide Dinitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-1772	Isosorbide Dinitrate	Isosorbide Dinitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0615-1575	Isosorbide Dinitrate	Isosorbide Dinitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6620	Isosorbide Dinitrate	Isosorbide Dinitrate	Major Pharmaceuticals	ANDA	Current
0904-6620	Isosorbide Dinitrate	Isosorbide Dinitrate	Major Pharmaceuticals	ANDA	Current
0904-6620	Isosorbide Dinitrate	Isosorbide Dinitrate	Major Pharmaceuticals	ANDA	Current
0904-6620	Isosorbide Dinitrate	Isosorbide Dinitrate	Major Pharmaceuticals	ANDA	Current
51407-149	Isosorbide Dinitrate	Isosorbide Dinitrate	Golden State Medical Supply Inc.	ANDA	Current
51407-149	Isosorbide Dinitrate	Isosorbide Dinitrate	Golden State Medical Supply, Inc.	ANDA	Current
51407-149	Isosorbide Dinitrate	Isosorbide Dinitrate	Golden State Medical Supply	ANDA	Current
51407-149	Isosorbide Dinitrate	Isosorbide Dinitrate	Golden State Medical Supply	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health	ANDA	Current
55154-7991	Isosorbide Dinitrate	Isosorbide Dinitrate	Cardinal Health 107, LLC	ANDA	Current
59115-130	Isosorbide	Isosorbide Dinitrate	Hikma Pharmaceutical	ANDA	Current
68001-375	Isosorbide	Isosorbide Dinitrate	BluePoint Laboratories	ANDA	Current