Application 200495

Type: ANDA
Sponsor: TORRENT 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	120MG	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
A200495-001	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-06-03
A200495-002	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB		2011-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200495-001	AB
A200495-002	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	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200495-001	ISOSORBIDE MONONITRATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200495-002	ISOSORBIDE MONONITRATE	120MG	TABLET, EXTENDED RELEASE / ORAL	AB	2011-06-03	`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	A200495-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200495-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200495-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200495-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200495-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200495-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200495-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200495-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200495-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200495-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200495-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200495-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200495-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200495-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200495-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200495-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200495-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200495-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200495-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200495-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200495-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200495-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200495-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200495-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200495-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200495-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200495-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200495-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200495-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200495-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200495-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200495-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200495-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200495-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200495-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200495-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200495-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200495-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200495-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200495-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health 107, LLC	72b8a20c-5833-4765-a4b5-9066eaec6ea1	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200495 application number: ANDA200495 ndc (product): 55154-7292
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	8cbb364a-bafe-454b-a53f-bd7cd69a5593	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200495 application number: ANDA200495 ndc (product): 0904-6450
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200495 application number: ANDA200495 ndc (product): 13668-106 ndc (product): 13668-105
Isosorbide Mononitrate	ISOSORBIDE MONONITRATE	American Health Packaging	6a582db5-eb45-4320-98c1-55517d7d8c38	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200495 application number: ANDA200495
ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	ba6120c8-c885-4cfa-b68e-9eee7a3bad6d	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200495 application number: ANDA200495 ndc (product): 0615-7768

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7768	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-7768	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6450	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	ANDA	Current
0904-6450	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	ANDA	Current
0904-6451	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Major Pharmaceuticals	ANDA	Current
10544-243	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Blenheim Pharmacal, Inc.	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-105	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
13668-106	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Torrent Pharmaceuticals Limited	ANDA	Current
55154-7292	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health	ANDA	Current
55154-7292	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health	ANDA	Current
55154-7292	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health	ANDA	Current
55154-7292	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health	ANDA	Current
55154-7292	ISOSORBIDE MONONITRATE	ISOSORBIDE MONONITRATE	Cardinal Health 107, LLC	ANDA	Current