Application 012093

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ISORDIL	ISOSORBIDE DINITRATE	TABLET;ORAL	40MG	Yes	Yes
002	ISORDIL	ISOSORBIDE DINITRATE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ISORDIL	ISOSORBIDE DINITRATE	TABLET;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	ISORDIL	ISOSORBIDE DINITRATE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	ISORDIL	ISOSORBIDE DINITRATE	TABLET;ORAL	5MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012093-001	ISORDIL	ISOSORBIDE DINITRATE	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29
N012093-002	ISORDIL	ISOSORBIDE DINITRATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-005	ISORDIL	ISOSORBIDE DINITRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-006	ISORDIL	ISOSORBIDE DINITRATE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29
N012093-007	ISORDIL	ISOSORBIDE DINITRATE	5MG	TABLET / ORAL	AB	RLD	1988-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N012093-001	AB
N012093-007	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-001	ISORDIL	40MG	TABLET / ORAL	AB	RLD, RS	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-002	ISORDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-005	ISORDIL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-006	ISORDIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-007	ISORDIL	5MG	TABLET / ORAL	AB	RLD	1988-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 79 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	N012093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012093-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012093-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012093-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012093-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012093-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012093-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012093-007	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012093-007	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012093-007	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012093-007	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012093-007	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012093-007	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012093-007	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012093-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012093-007	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012093-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012093-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012093-007	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012093-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012093-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012093-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012093-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012093-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012093-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012093-007	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012093-001	AB	1	`87673890dc5c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isosorbide Dinitrate	ISOSORBIDE DINITRATE	Oceanside Pharmaceuticals	723d9f78-9d77-4575-af27-1aa117e6b8d7	2020-03-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012093 application number: NDA012093 ndc (product): 68682-192 ndc (product): 68682-193

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0152	Isordil	isosorbide dinitrate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0152	Isordil	isosorbide dinitrate	Bausch Health Americas, Inc	NDA	Current
0187-0152	Isordil	isosorbide dinitrate	Bausch Health US LLC	NDA	Current
0187-0152	Isordil	isosorbide dinitrate	Bausch Health US LLC	NDA	Current
0187-0192	Isordil	isosorbide dinitrate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0192	Isordil	isosorbide dinitrate	Bausch Health Americas, Inc	NDA	Current
0187-0192	Isordil	isosorbide dinitrate	Bausch Health US LLC	NDA	Current
0187-0192	Isordil	isosorbide dinitrate	Bausch Health US LLC	NDA	Current
68682-192	Isosorbide Dinitrate	isosorbide dinitrate	Oceanside Pharmaceuticals	NDA	Current
68682-193	Isosorbide Dinitrate	isosorbide dinitrate	Oceanside Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11987	SUPPL	2015-01-16
33072	SUPPL	2015-01-15
11986	SUPPL	2001-09-26