Application 075041

Type: ANDA
Sponsor: ALKERMES GAINESVILLE

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

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

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
A075041-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL			1998-09-22

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075041-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	1998-09-22	`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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	ba6120c8-c885-4cfa-b68e-9eee7a3bad6d	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	63dc518f-4f86-4820-98c2-5de8aed09a4b	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	NuCare Pharmaceuticals,Inc.	65935a15-a023-1941-e053-2991aa0a5eb4	2024-06-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	17525ff2-9ec0-15a1-e063-6394a90ab762	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	441ddd35-6cb8-44d0-8009-1635390ede83	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	0af6c67f-919d-4515-8074-f6c3aaa835b5	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Aphena Pharma Solutions - Tennessee, LLC	18cf36bc-e73f-4274-b381-c2f2aa02f57d	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	adcca9b8-0505-4bbc-81ab-05efc7407b6b	2024-01-23	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	A-S Medication Solutions	4da5a0ac-574d-48ea-80ba-55344bfefb91	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	A-S Medication Solutions	44a0f691-b826-4580-ab2d-b5d1cc99e283	2023-11-09	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Ingenus Pharmaceuticals, LLC	c950760f-0e32-483f-96f2-eecaf057c0ec	2023-10-27	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	96420729-2bc7-4d03-9c51-f786ea678998	2023-10-26	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	A-S Medication Solutions	5a8164a3-56e2-4b9b-8718-0423b4b4958f	2023-09-05	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Aurobindo Pharma Limited	55810c9d-1140-40b8-a297-210a84afc05a	2022-11-11	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Actavis Pharma, Inc.	ae8f74f0-e600-4452-8557-958b603e2709	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Lannett Company, Inc.	bf9e7e35-7707-42a0-88d6-6292fa52bbfa	2020-06-05	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Proficient Rx LP	f871dfa7-219f-4704-8e4d-215caeb7408d	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22404	ORIG	1998-09-22
18381	ORIG	1998-09-22
8496	ORIG	1998-09-22