Application 086054

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;SUBLINGUAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086054-001	ISOSORBIDE DINITRATE	2.5MG	TABLET / SUBLINGUAL	1987-10-29	`cb3db0bc1861…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	6df6a2fa-c56c-4eb6-a485-c16585420eb0	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	3d6164d7-3083-41c5-a6a6-7e144fe29f7d	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Cardinal Health 107, LLC	5f585259-59ed-4648-b562-164f3746c821	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Major Pharmaceuticals	6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	AvPAK	0e5842f2-74f6-1f02-01bc-07578bd3b393	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	REMEDYREPACK INC.	829ed058-333f-453c-9f0e-9202e03acf97	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE DINITRATE generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Golden State Medical Supply, Inc.	7f860fbd-f130-4652-e053-2991aa0a402e	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Advagen Pharma Ltd	b166eb5b-bad8-4663-9c05-1c43539dab2c	2026-01-05	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE DINITRATE generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Hikma Pharmaceuticals USA Inc.	f0b9b320-0bf8-4342-b654-135ccb6755c2	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	American Health Packaging	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Northstar Rx LLC	246c749d-aa28-44ce-8d42-984660afff2a	2025-08-21	Warnings, Adverse reactions	Name fallback brand name: Isosorbide dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Bryant Ranch Prepack	73a1e6c0-71d0-4ba1-bbca-c067479e487d	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrate	ISOSORBIDE DINITRATE	BluePoint Laboratories	f1d52e9a-8de1-61db-e053-2a95a90aae50	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: Isosorbide dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Pharmaceuticals (USA) Inc.	16818b32-ee5e-4e07-b848-31e892c4b98a	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Isosorbide dinitrate generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20	2024-08-01	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE DINITRATE generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	33d14f59-3ae8-4414-b826-06274cf0f3d9	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE DINITRATE generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Sandoz Inc.	71fdd147-a987-40b6-9f07-82d56525ceb8	2024-02-01	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Lifesciences Limited	5b0db8af-bcf9-458f-b752-420130cba428	2023-11-07	Warnings, Adverse reactions	Name fallback brand name: Isosorbide dinitrate generic name: ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	74a7f767-fa2f-4640-be24-34a8a9128217	2023-05-22	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE DINITRATE generic name: ISOSORBIDE DINITRATE
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Oceanside Pharmaceuticals	723d9f78-9d77-4575-af27-1aa117e6b8d7	2020-03-02	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Dinitrate generic name: ISOSORBIDE DINITRATE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1765	Isosorbide Dinitrate	Isosorbide Dinitrate	West-ward Pharmaceutical Corp	ANDA	Current

Application 086054

Related Records#

Application Products#

Observed Orange Book product history#

openFDA label cross-check#

NDC Listings For This Application#