Application 076813

Type: ANDA
Sponsor: HIKMA INTL PHARMS

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 42.

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
A076813-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL			2005-01-07
A076813-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL			2006-03-30

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 · 84 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	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2005-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076813-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2005-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076813-002	ISOSORBIDE MONONITRATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2006-03-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076813-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076813-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076813-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076813-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076813-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076813-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076813-002	AB	1	`ea99ee380514…`

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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	REMEDYREPACK INC.	d01d4f0f-5164-4ea3-b772-72b97961c6fb	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	55f240e1-3056-38cc-e063-6294a90a814e	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health 107, LLC	72b8a20c-5833-4765-a4b5-9066eaec6ea1	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	8cbb364a-bafe-454b-a53f-bd7cd69a5593	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Genus Lifesciences Inc.	0d739bf3-0672-4504-9064-b39d6b200b47	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	ANI Pharmaceuticals, Inc.	06839534-85b8-42aa-b0e3-079ed236be44	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Shandong New Time Pharmaceutical Co., Ltd.	cd953cfa-b6f5-4b82-afcc-52a57236b9d3	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Northwind Health Company, LLC	df5fd5e2-3a7b-5a5b-e053-2995a90a0dd3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	46b3030d-f492-da9d-e063-6294a90a31b3	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Chartwell RX, LLC	b38f43c8-d02d-4aee-ab23-e898cbfadfbc	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	American Health Packaging	6a582db5-eb45-4320-98c1-55517d7d8c38	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	3e0e013f-6887-fa72-e063-6294a90a18ca	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	Coupler LLC	3dffc84e-93e4-0005-e063-6294a90aa9ca	2025-09-04	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Bryant Ranch Prepack	cd60ded0-01d9-4a51-a8ad-cdfeb27d88fb	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
isosorbide mononitrate	ISOSORBIDE MONONITRATE	OMNIVIUM PHARMACEUTICALS LLC.	cdf01e14-778b-4b3f-8372-1c18f266fb98	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: isosorbide mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Edenbridge Pharmaceuticals LLC.	7443a5b6-6153-4227-870c-3c710f1f2174	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	Edenbridge Pharmaceuticals LLC.	0e3c4461-2e04-481f-a9e5-29f21cc71ec5	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Isosorbide Mononitrate generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Coupler LLC	2d99893a-296a-134c-e063-6294a90ace3b	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	A-S Medication Solutions	5fd86c08-18de-43a2-9962-ab6cbf57d6c0	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: ISOSORBIDE MONONITRATE generic name: ISOSORBIDE MONONITRATE

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
0143-2230	Isosorbide	Isosorbide mononitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-2230	Isosorbide	Isosorbide mononitrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-2230	Isosorbide	Isosorbide mononitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-2260	Isosorbide	Isosorbide mononitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-2260	Isosorbide	Isosorbide mononitrate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-2260	Isosorbide	Isosorbide mononitrate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0615-4544	Isosorbide Mononitrate	Isosorbide mononitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-4546	Isosorbide Mononitrate	Isosorbide mononitrate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
68071-4390	Isosorbide	Isosorbide mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4390	Isosorbide	Isosorbide mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4689	Isosorbide	Isosorbide mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4689	Isosorbide	Isosorbide mononitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68151-1418	Isosorbide	Isosorbide mononitrate	Carilion Materials Management	ANDA	Current
71335-0739	Isosorbide	Isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current
71335-0739	Isosorbide	Isosorbide mononitrate	Bryant Ranch Prepack	ANDA	Current