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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide	ISOSORBIDE DINITRATE	BluePoint Laboratories	9498fa14-1614-4a8e-b872-41c11745b01e	2018-11-30	Warnings, Adverse reactions	Name fallback generic name: ISOSORBIDE DINITRATE

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 · 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