Application 017814

Type: NDA
Sponsor: EGALET

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOCIN	INDOMETHACIN	SUPPOSITORY;RECTAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017814-001	INDOCIN	INDOMETHACIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL		RLD	1984-08-13

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 2 · 43 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	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017814-001	INDOCIN	50MG	SUPPOSITORY / RECTAL	RLD	1984-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017814-001	INDOCIN	50MG	SUPPOSITORY / RECTAL	RLD	1984-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`f41ea6bd6efb…`

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 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 brand name: INDOCIN 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
INDOMETHACIN	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	85014b51-1354-4d16-9995-3ee33a7155fa	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	2025-03-31	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80340	SUPPL	2024-11-25
80297	SUPPL	2024-11-22
80296	SUPPL	2024-11-22
67335	SUPPL	2021-05-03
67334	SUPPL	2021-05-03
67225	SUPPL	2021-04-29
58125	SUPPL	2019-03-28
58087	SUPPL	2019-03-27
58086	SUPPL	2019-03-27
33352	SUPPL	2016-05-11
13910	SUPPL	2016-05-11
11068	SUPPL	2016-05-11
713	SUPPL	2016-05-11
33351	SUPPL	2007-02-02
13909	SUPPL	2007-02-02
11067	SUPPL	2006-01-27
712	SUPPL	2005-03-29