Application 091401

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	25MG	No	No
002	INDOMETHACIN	INDOMETHACIN	CAPSULE;ORAL	50MG	No	No

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
A091401-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL			2013-03-28
A091401-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL			2013-03-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091401-001	INDOMETHACIN	25MG	CAPSULE / ORAL	2013-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091401-002	INDOMETHACIN	50MG	CAPSULE / ORAL	2013-03-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A091401-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091401-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091401-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091401-002	AB	1	`ea99ee380514…`

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 brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	67b16cf2-e24c-4fe3-8d74-e63549b7659f	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	2f4a5796-5317-4caa-83e4-0595fe844df4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Chartwell RX, LLC	9607920c-4d25-40b9-957e-87e9ca5574e8	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	KVK-Tech, Inc.	dc80228c-acae-44dc-9762-19bd1669bf45	2025-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	AvPAK	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin 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 generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Hikma Pharmaceuticals USA Inc.	2033059b-4be1-42d0-b888-34d8202f3e09	2024-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Amneal Pharmaceuticals NY LLC	8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	175a2d81-0d0f-46a3-aaaa-1732982d85fd	2024-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9236d783-d7b8-4486-94c6-5ecd876bc475	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	56e19868-3973-4f1b-b80f-1f7daf1f1c22	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	7c911ac4-db70-44bf-8374-01c8260aa3d4	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Zydus Pharmaceuticals USA Inc.	595e2f3e-c6d4-4a17-bc06-46512b4275b5	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	c6126527-5272-4477-8716-d05365a05225	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9ce37860-407f-47c7-a64c-62b6cc729298	2024-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	afbb24fd-3695-4a30-a8a6-36239e35a14f	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-119	INDOMETHACIN	indomethacin	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-120	INDOMETHACIN	indomethacin	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current