Application 201807

Type: ANDA
Sponsor: HETERO LABS LTD III

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
A201807-001	INDOMETHACIN	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201807-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2012-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	INDOMETHACIN	75MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2012-09-28	`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	A201807-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201807-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201807-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201807-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201807-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201807-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201807-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201807-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201807-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201807-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201807-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201807-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201807-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201807-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201807-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201807-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201807-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201807-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201807-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201807-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201807-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201807-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201807-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201807-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201807-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201807-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201807-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201807-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201807-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201807-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201807-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201807-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201807-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201807-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201807-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201807-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201807-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201807-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201807-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201807-001	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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 70518-0515
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	f2f59f63-fcda-2a80-e053-2995a90ab087	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	efa111d5-ade4-4944-97e4-3c37b8b14ea8	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 71335-0756
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	12f62bae-5fc0-4f8d-a8b4-446524bd53d1	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 31722-565
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	d54d6e12-e827-4248-819a-de76afa70371	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin ER	INDOMETHACIN	Advanced Rx Pharmacy of Tennessee, LLC	f4e8a719-ef9c-a2ef-e053-2995a90ad788	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	c6126527-5272-4477-8716-d05365a05225	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 63629-1915
Indomethacin	INDOMETHACIN	Proficient Rx LP	ac458b4b-95bb-4235-a447-e8c4ba720257	2023-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807
Indomethacin	INDOMETHACIN	Asclemed USA, Inc.	dfdcdb27-07a0-47e6-b8da-d9c99045a066	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201807 application number: ANDA201807 ndc (product): 76420-029

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-935	Indomethacin	Indomethacin	Blenheim Pharmacal, Inc.	ANDA	Current
31722-565	Indomethacin	Indomethacin	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-565	Indomethacin	Indomethacin	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-2715	Indomethacin	Indomethacin	A-S Medication Solutions	ANDA	Current
50268-432	Indomethacin	Indomethacin	AvPAK	ANDA	Current
50268-432	Indomethacin	Indomethacin	AvPAK	ANDA	Current
61919-344	INDOMETHACIN	INDOMETHACIN	Direct RX	ANDA	Current
63629-1915	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
63629-1915	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
68071-3060	Indomethacin	Indomethacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3060	Indomethacin	Indomethacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3060	Indomethacin	Indomethacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70518-0515	Indomethacin	Indomethacin	REMEDYREPACK INC.	ANDA	Current
70934-031	Indomethacin	Indomethacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-031	Indomethacin	Indomethacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-031	Indomethacin	Indomethacin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0756	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
71335-0756	Indomethacin	Indomethacin	Bryant Ranch Prepack	ANDA	Current
76420-029	Indomethacin	Indomethacin	Asclemed USA, Inc.	ANDA	Current
76420-029	Indomethacin	Indomethacin	Asclemed USA, Inc.	ANDA	Current