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001	INDOCIN	INDOMETHACIN	SUPPOSITORY;RECTAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N017814-001	INDOCIN	INDOMETHACIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL		RLD	1984-08-13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N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`84e616aacf4f…`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N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`caaa826d4ba7…`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UTC	2026-02	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`011fe1cb6892…`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of this ZIP	2025-12	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`31067a03dcf5…`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UTC	2025-08	N017814-001	INDOCIN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD	1984-08-13	`6a471c1ec25d…`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 3 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	d54d6e12-e827-4248-819a-de76afa70371	2025-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	67b16cf2-e24c-4fe3-8d74-e63549b7659f	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	2f4a5796-5317-4caa-83e4-0595fe844df4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Chartwell RX, LLC	9607920c-4d25-40b9-957e-87e9ca5574e8	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	KVK-Tech, Inc.	dc80228c-acae-44dc-9762-19bd1669bf45	2025-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	AvPAK	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin ER	INDOMETHACIN	Advanced Rx Pharmacy of Tennessee, LLC	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indocin	INDOMETHACIN	Zyla Life Sciences US LLC	73878376-1d24-423b-9f37-3666e83c95da	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indocin generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Hikma Pharmaceuticals USA Inc.	2033059b-4be1-42d0-b888-34d8202f3e09	2024-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals NY LLC	8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	175a2d81-0d0f-46a3-aaaa-1732982d85fd	2024-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9236d783-d7b8-4486-94c6-5ecd876bc475	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	56e19868-3973-4f1b-b80f-1f7daf1f1c22	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	7c911ac4-db70-44bf-8374-01c8260aa3d4	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	595e2f3e-c6d4-4a17-bc06-46512b4275b5	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	c6126527-5272-4477-8716-d05365a05225	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9ce37860-407f-47c7-a64c-62b6cc729298	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	afbb24fd-3695-4a30-a8a6-36239e35a14f	2024-08-19	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