Application 086925

Type: ANDA
Sponsor: PAR PHARM

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A086925-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB		1987-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086925-001	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 · 42 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	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086925-001	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	1987-03-12	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A086925-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086925-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086925-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086925-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086925-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086925-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086925-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086925-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086925-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086925-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086925-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086925-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086925-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086925-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086925-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086925-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086925-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086925-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086925-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086925-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086925-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086925-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086925-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086925-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086925-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086925-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086925-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086925-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086925-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086925-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086925-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086925-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086925-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086925-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086925-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086925-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086925-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086925-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086925-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086925-001	AB	1	`e64feba35796…`

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
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Par Health USA, LLC	6df6a2fa-c56c-4eb6-a485-c16585420eb0	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086925 application number: ANDA086925 ndc (product): 49884-021
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	AvPAK	0e5842f2-74f6-1f02-01bc-07578bd3b393	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086925 application number: ANDA086925 ndc (product): 50268-448
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	American Health Packaging	5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086925 application number: ANDA086925 ndc (product): 68084-082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8157	Isosorbide Dinitrate	isosorbide dinitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-139	Isosorbide Dinitrate	isosorbide dinitrate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
49884-021	Isosorbide Dinitrate	isosorbide dinitrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-021	Isosorbide Dinitrate	isosorbide dinitrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-021	Isosorbide Dinitrate	isosorbide dinitrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-021	Isosorbide Dinitrate	isosorbide dinitrate	Par Pharmaceutical, Inc.	ANDA	Current
49884-021	Isosorbide Dinitrate	isosorbide dinitrate	Par Pharmaceutical, Inc.	ANDA	Current
50268-448	Isosorbide Dinitrate	Isosorbide Dinitrate	AvPAK	ANDA	Current
50268-448	Isosorbide Dinitrate	Isosorbide Dinitrate	AvPAK	ANDA	Current
60429-441	Isosorbide Dinitrate	isosorbide dinitrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-441	Isosorbide Dinitrate	isosorbide dinitrate	Golden State Medical Supply, Inc.	ANDA	Current
63739-569	Isosorbide Dinitrate	isosorbide dinitrate	McKesson Corporation	ANDA	Current
63739-569	Isosorbide Dinitrate	isosorbide dinitrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-569	Isosorbide Dinitrate	isosorbide dinitrate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-569	Isosorbide Dinitrate	isosorbide dinitrate	McKesson Corporation dba SKY Packaging	ANDA	Current
68084-082	Isosorbide Dinitrate	Isosorbide Dinitrate	American Health Packaging	ANDA	Current
68084-082	Isosorbide Dinitrate	Isosorbide Dinitrate	American Health Packaging	ANDA	Current
68084-082	Isosorbide Dinitrate	Isosorbide Dinitrate	American Health Packaging	ANDA	Current
68084-082	Isosorbide Dinitrate	Isosorbide Dinitrate	American Health Packaging	ANDA	Current
68084-082	Isosorbide Dinitrate	Isosorbide Dinitrate	American Health Packaging	ANDA	Current
70518-2817	Isosorbide Dinitrate	isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current
70518-2817	Isosorbide Dinitrate	isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current