Application 204768

Type: NDA
Sponsor: GENUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIVORBEX	INDOMETHACIN	CAPSULE;ORAL	20MG	Yes	No
002	TIVORBEX	INDOMETHACIN	CAPSULE;ORAL	40MG	Yes	Yes

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
N204768-001	TIVORBEX	INDOMETHACIN	20MG	CAPSULE / ORAL		RLD	2014-02-24
N204768-002	TIVORBEX	INDOMETHACIN	40MG	CAPSULE / ORAL		RLD	2014-02-24

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204768-001	8734847	2030-04-23		Drug product	2014-05-27
N204768-001	8992982	2030-04-23		Drug product	2015-04-03
N204768-001	9089471	2030-04-23	U-55		2015-07-27
N204768-002	8734847	2030-04-23		Drug product	2014-05-27
N204768-002	8992982	2030-04-23		Drug product	2015-04-03
N204768-002	9089471	2030-04-23	U-55		2015-07-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD, RS	2014-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`2680178bc6a6…`

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	Fresenius Kabi USA, LLC	ec482425-358c-4500-8f5d-79c1379c1fa8	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	7755391e-ede3-4a32-854c-736dc6dd2ee3	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	927af761-2f37-4e81-a86e-d4fb17cc1897	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	c9f4eda2-5c8f-72eb-e053-2a95a90a06be	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	f2f59f63-fcda-2a80-e053-2995a90ab087	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	db0f1127-ebd8-636c-e053-2a95a90a4d44	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	NorthStar RxLLC	6bb30cef-c460-4696-8acd-a453408640f4	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Glenmark Pharmaceuticals Inc., USA	f7ed39e2-5431-4e47-935c-c7441d058f94	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOCIN	INDOMETHACIN	Zyla Life Sciences US Inc.	3b36645c-de5e-4263-ae06-2f6ff6a9add2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Chartwell RX, LLC	d35bafd6-076d-4b94-bb0f-99be0addb505	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
indomethacin	INDOMETHACIN	Glenmark Pharmaceuticals Inc., USA	532d40b2-c05c-4d4f-b7ee-e6434c4c27fc	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	971c4d53-7876-4f42-ba2d-c391714fa341	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	American Health Packaging	5a65b650-ea9b-4d0d-b62f-5971df1e62b4	2025-10-28	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	5b05b8bc-4df0-4175-bf53-72129fb21b50	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	a329976b-4a01-42ea-a666-0ac99ed2522e	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	efa111d5-ade4-4944-97e4-3c37b8b14ea8	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	c81343f2-5ef5-4635-9b94-5ac8d72aa61e	2025-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	1ce9c3c5-0cf7-4760-988d-2559adcfb200	2025-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	2025-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42211-201	Tivorbex	indomethacin	Iroko Pharmaceuticals, LLC	NDA	Current
42211-202	Tivorbex	indomethacin	Iroko Pharmaceuticals, LLC	NDA	Current
69344-201	Tivorbex	indomethacin	Egalet US Inc.	NDA	Current
69344-202	Tivorbex	indomethacin	Egalet US Inc.	NDA	Current
69597-350	Tivorbex	indomethacin	Basiem	NDA	Current
69597-350	Tivorbex	indomethacin	Basiem	NDA	Current
69597-350	Tivorbex	indomethacin	Basiem	NDA	Current
69597-350	Tivorbex	indomethacin	Basiem	NDA	Current
73308-349	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-349	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-349	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-349	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-350	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-350	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-350	Indomethacin	indomethacin	Ayurax	NDA	Current
73308-350	Indomethacin	indomethacin	Ayurax	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67375	SUPPL	2021-05-03
67374	SUPPL	2021-05-03
67288	SUPPL	2021-04-30
58129	SUPPL	2019-03-28
58078	SUPPL	2019-03-26
58075	SUPPL	2019-03-26
43974	SUPPL	2016-05-18
19597	SUPPL	2016-05-11
19596	SUPPL	2016-05-11
10393	SUPPL	2016-05-10
10392	SUPPL	2016-05-10
44909	ORIG	2014-08-07
22965	ORIG	2014-08-07
10391	ORIG	2014-02-26
19595	ORIG	2014-02-25