Application 215723

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	5MG	No	No
002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	10MG	No	No
003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	20MG	No	No
004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	30MG	No	No
005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	TABLET;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215723-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08
A215723-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08
A215723-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08
A215723-004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08
A215723-005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215723-001	AB
A215723-002	AB
A215723-003	AB
A215723-004	AB
A215723-005	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 4 · 140 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	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2022-07-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A215723-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215723-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215723-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215723-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215723-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215723-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215723-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215723-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215723-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215723-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215723-005	AB	1	`2680178bc6a6…`

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	REMEDYREPACK INC.	829ed058-333f-453c-9f0e-9202e03acf97	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Advagen Pharma Ltd	b166eb5b-bad8-4663-9c05-1c43539dab2c	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723 ndc (product): 72888-082 ndc (product): 72888-081 ndc (product): 72888-083 ndc (product): 72888-085 ndc (product): 72888-084
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	Proficient Rx LP	33d14f59-3ae8-4414-b826-06274cf0f3d9	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723
ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	74a7f767-fa2f-4640-be24-34a8a9128217	2023-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215723 application number: ANDA215723

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-081	ISOSORBIDE DINITRATE	isosorbide dinitrate	Advagen Pharma Ltd	ANDA	Current
72888-082	ISOSORBIDE DINITRATE	isosorbide dinitrate	Advagen Pharma Ltd	ANDA	Current
72888-083	ISOSORBIDE DINITRATE	isosorbide dinitrate	Advagen Pharma Ltd	ANDA	Current
72888-084	ISOSORBIDE DINITRATE	isosorbide dinitrate	Advagen Pharma Ltd	ANDA	Current
72888-085	ISOSORBIDE DINITRATE	isosorbide dinitrate	Advagen Pharma Ltd	ANDA	Current