Application 075522

Type: ANDA
Sponsor: DEXCEL LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075522-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-04-17
A075522-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075522-001	AB
A075522-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075522-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075522-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-09-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075522-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075522-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075522-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075522-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075522-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075522-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075522-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075522-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075522-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075522-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075522-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075522-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075522-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075522-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075522-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075522-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075522-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075522-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075522-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075522-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075522-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075522-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075522-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075522-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075522-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075522-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075522-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075522-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075522-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075522-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075522-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075522-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075522-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075522-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075522-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075522-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075522-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075522-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075522-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075522-002	AB	1	`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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	46b3030d-f492-da9d-e063-6294a90a31b3	2025-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Chartwell RX, LLC	b38f43c8-d02d-4aee-ab23-e898cbfadfbc	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	cd60ded0-01d9-4a51-a8ad-cdfeb27d88fb	2025-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Edenbridge Pharmaceuticals LLC.	0e3c4461-2e04-481f-a9e5-29f21cc71ec5	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	NuCare Pharmaceuticals,Inc.	65935a15-a023-1941-e053-2991aa0a5eb4	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075522 application number: ANDA075522 ndc (product): 68071-4290

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 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-178	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-178	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-178	Isosorbide Mononitrate	Isosorbide Mononitrate	Avet Pharmaceuticals Inc.	ANDA	Current
23155-178	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-519	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-519	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-519	Isosorbide Mononitrate	Isosorbide Mononitrate	Avet Pharmaceuticals Inc.	ANDA	Current
23155-519	Isosorbide Mononitrate	Isosorbide Mononitrate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50090-4009	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50090-4009	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50090-4009	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50090-4047	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50090-4047	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50090-4047	Isosorbide Mononitrate	Isosorbide Mononitrate	A-S Medication Solutions	ANDA	Current
50436-3945	Isosorbide Mononitrate	Isosorbide Mononitrate	Unit Dose Services	ANDA	Current
53002-1570	Isosorbide Mononitrate	Isosorbide Mononitrate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1570	Isosorbide Mononitrate	Isosorbide Mononitrate	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-3081	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3081	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3081	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4290	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4290	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4290	Isosorbide Mononitrate	Isosorbide Mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2122	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2207	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2207	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2207	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2207	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2692	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2692	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-2692	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70934-183	Isosorbide Mononitrate	Isosorbide Mononitrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-183	Isosorbide Mononitrate	Isosorbide Mononitrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-972	Isosorbide Mononitrate	Isosorbide Mononitrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0037	Isosorbide Mononitrate	Isosorbide Mononitrate	Bryant Ranch Prepack	ANDA	Current
71335-0037	Isosorbide Mononitrate	Isosorbide Mononitrate	Bryant Ranch Prepack	ANDA	Current
71335-0037	Isosorbide Mononitrate	Isosorbide Mononitrate	Bryant Ranch Prepack	ANDA	Current
71335-1117	Isosorbide Mononitrate	Isosorbide Mononitrate	Bryant Ranch Prepack	ANDA	Current
71335-1117	Isosorbide Mononitrate	Isosorbide Mononitrate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43000	ORIG	2000-04-17
30922	ORIG	2000-04-17