Application 213057

Type: ANDA
Sponsor: ZYDUS

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
A213057-001	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20
A213057-002	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20
A213057-003	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20
A213057-004	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20
A213057-005	ISOSORBIDE DINITRATE	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213057-001	AB
A213057-002	AB
A213057-003	AB
A213057-004	AB
A213057-005	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 5 · 195 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	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-001	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-002	ISOSORBIDE DINITRATE	10MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-003	ISOSORBIDE DINITRATE	20MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-004	ISOSORBIDE DINITRATE	30MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-005	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 195 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	A213057-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213057-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213057-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213057-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213057-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213057-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213057-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213057-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213057-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213057-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213057-005	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Northstar Rx LLC	246c749d-aa28-44ce-8d42-984660afff2a	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057 ndc (product): 16714-008 ndc (product): 16714-007 ndc (product): 16714-010 ndc (product): 16714-009
Isosorbide dinitrate	ISOSORBIDE DINITRATE	BluePoint Laboratories	f1d52e9a-8de1-61db-e053-2a95a90aae50	2024-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Pharmaceuticals (USA) Inc.	16818b32-ee5e-4e07-b848-31e892c4b98a	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057 ndc (product): 70710-1148 ndc (product): 70710-1150 ndc (product): 70710-1149 ndc (product): 70710-1151 ndc (product): 70710-1152
Isosorbide dinitrate	ISOSORBIDE DINITRATE	Zydus Lifesciences Limited	5b0db8af-bcf9-458f-b752-420130cba428	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213057 application number: ANDA213057 ndc (product): 70771-1503 ndc (product): 70771-1501 ndc (product): 70771-1502 ndc (product): 70771-1505 ndc (product): 70771-1504

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-007	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-008	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-009	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
16714-010	Isosorbide dinitrate	Isosorbide dinitrate	Northstar Rx LLC	ANDA	Current
70518-3444	Isosorbide dinitrate	Isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current
70518-3444	Isosorbide dinitrate	Isosorbide dinitrate	REMEDYREPACK INC.	ANDA	Current
70710-1148	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1148	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1149	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1149	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1150	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1150	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1151	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1151	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1152	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1152	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1501	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1501	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1502	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1502	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1503	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1503	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1504	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1504	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current
70771-1505	Isosorbide dinitrate	Isosorbide dinitrate	Zydus Lifesciences Limited	ANDA	Current
70771-1505	Isosorbide dinitrate	Isosorbide dinitrate	Cadila Healthcare Limited	ANDA	Current