Application 075037

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET;ORAL	20MG	No	No
002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075037-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB		1998-10-30
A075037-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB		1998-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075037-001	AB
A075037-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075037-001	ISOSORBIDE MONONITRATE	20MG	TABLET / ORAL	AB	1998-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075037-002	ISOSORBIDE MONONITRATE	10MG	TABLET / ORAL	AB	1998-10-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075037-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075037-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075037-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075037-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075037-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075037-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075037-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075037-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075037-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075037-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075037-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075037-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075037-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075037-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075037-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075037-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075037-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075037-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075037-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075037-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075037-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075037-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075037-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075037-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075037-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075037-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075037-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075037-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075037-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075037-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075037-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075037-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075037-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075037-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075037-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075037-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075037-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075037-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075037-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075037-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Genus Lifesciences Inc.	0d739bf3-0672-4504-9064-b39d6b200b47	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075037 application number: ANDA075037
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Actavis Pharma, Inc.	ae8f74f0-e600-4452-8557-958b603e2709	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075037 application number: ANDA075037 ndc (product): 0228-2631 ndc (product): 0228-2620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2620	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0228-2620	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0228-2620	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0228-2631	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0228-2631	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0228-2631	Isosorbide Mononitrate	Isosorbide Mononitrate	Actavis Pharma, Inc.	ANDA	Current
0615-5549	Isosorbide Mononitrate	Isosorbide Mononitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-5550	Isosorbide Mononitrate	Isosorbide Mononitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-1485	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current
70518-3081	Isosorbide Mononitrate	Isosorbide Mononitrate	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30737	ORIG	1998-10-30