Application 200529

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDOMETHACIN	INDOMETHACIN	CAPSULE, EXTENDED RELEASE;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200529-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2010-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200529-001	AB

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200529-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2010-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200529-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200529-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200529-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200529-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200529-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200529-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200529-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200529-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200529-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200529-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200529-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200529-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200529-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200529-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200529-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200529-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200529-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200529-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200529-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200529-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200529-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200529-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200529-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200529-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200529-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200529-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200529-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200529-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200529-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200529-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200529-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200529-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200529-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200529-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200529-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200529-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200529-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200529-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200529-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200529-001	AB	1	`cb3db0bc1861…`

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