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 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204768-001	TIVORBEX	20MG	CAPSULE / ORAL	RLD	2014-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-002	TIVORBEX	40MG	CAPSULE / ORAL	RLD	2014-02-24	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204768-001	8734847	2030-04-23		Drug product	2014-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-001	8992982	2030-04-23		Drug product	2015-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-001	9089471	2030-04-23	U-55		2015-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-002	8734847	2030-04-23		Drug product	2014-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-002	8992982	2030-04-23		Drug product	2015-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204768-002	9089471	2030-04-23	U-55		2015-07-27	`caaa826d4ba7…`
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…`

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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	3e87e34a-6556-4b0f-e054-00144ff8d46c	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	3e8796a6-94c6-0db2-e054-00144ff88e88	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals LLC	dbad7e61-2347-43b1-a422-9183e41c10ea	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	NuCare Pharmaceuticals, Inc.	503455d9-471e-554f-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	DIRECT RX	4d9a253a-f014-4fab-e054-00144ff8d46c	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Lifesciences Limited	c6ca86fb-df23-42c1-9d29-f15312faf60c	2023-08-03		Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	ac458b4b-95bb-4235-a447-e8c4ba720257	2023-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Fresenius Kabi USA, LLC	30e38747-c553-4e2d-bc23-634e1dd90b8d	2023-06-16	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Fresenius Kabi USA, LLC	dd5caa3f-3c09-4034-bf43-2df80c61c07b	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	XLCare Pharmaceuticals Inc.	bc8a572d-e0e1-4d37-b3c4-b85415d50393	2023-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	66e3205b-eab1-4864-bf36-116e9d79fe3e	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2022-10-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	86c94559-b453-4e61-a76c-6962872f0655	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	b094eb04-3177-431d-b5ac-edc4804750a2	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	9c15102c-b6f9-4198-b592-152160591014	2022-07-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Proficient Rx LP	8aa48212-19b0-4304-9c61-dcf4db2b19ea	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN

Reported adverse events (FAERS/openFDA)#

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

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