Application 087545

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;SUBLINGUAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A087545-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL			1986-09-18

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087545-001	ISOSORBIDE DINITRATE	10MG	TABLET / SUBLINGUAL	1986-09-18	`f41ea6bd6efb…`

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.