Application 090403

Type: ANDA
Sponsor: CADILA

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 1.

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
A090403-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2010-11-15
A090403-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2010-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090403-001	AB
A090403-002	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 3 · 82 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	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090403-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2010-11-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090403-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2010-11-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090403-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090403-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090403-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090403-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090403-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090403-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090403-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090403-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090403-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090403-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090403-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090403-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090403-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090403-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090403-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090403-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090403-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090403-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090403-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090403-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090403-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090403-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090403-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090403-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090403-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090403-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090403-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090403-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090403-002	AB	1	`782e0a99824c…`

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 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	bf93022c-a965-49c5-a852-c59e580d7d91	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	205fc4e7-e118-509e-e063-6394a90a78e6	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	009097a5-2c1e-4f5d-8054-896cf896cb3d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	99d7a84b-c755-47be-9d2d-1223162b0a42	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	bf11f5a0-f2ee-499a-8d54-9d557cc66841	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	1bb80a9f-def3-4228-ab04-a0c2a117a2b9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Coupler LLC	51266787-b50e-bc15-e063-6394a90ad16f	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	6312c9a6-d4d3-eb1f-e053-2991aa0a5e68	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	b4cf01d1-0d71-4f0f-97a5-07a59744149f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	REMEDYREPACK INC.	16238287-d4b0-4afa-8483-1f4ae250a625	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	Sportpharm LLC	12821a3a-b5f2-4415-84c9-0a30a4725f1e	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	Bryant Ranch Prepack	41af7776-36bc-4820-b635-e7c69f26997e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: INDOMETHACIN generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	ANI Pharmaceuticals, Inc.	e8b86758-6cb5-44ac-a5fc-2111e98a19a8	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN
Indomethacin	INDOMETHACIN	RedPharm Drug, Inc.	4d9ef14a-4812-4fcf-e054-00144ff8d46c	2026-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Indomethacin generic name: INDOMETHACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42708-030	indomethacin	indomethacin	QPharma Inc	ANDA	Current
42708-030	indomethacin	indomethacin	QPharma Inc	ANDA	Current
50090-2821	indomethacin	indomethacin	A-S Medication Solutions	ANDA	Current
50090-3014	indomethacin	indomethacin	A-S Medication Solutions	ANDA	Current
50090-3022	indomethacin	indomethacin	A-S Medication Solutions	ANDA	Current
50090-3097	indomethacin	indomethacin	A-S Medication Solutions	ANDA	Current
63187-852	indomethacin	indomethacin	Proficient Rx LP	ANDA	Current
63187-852	indomethacin	indomethacin	Proficient Rx LP	ANDA	Current
67296-1512	indomethacin	indomethacin	RedPharm Drug, Inc.	ANDA	Current
67296-1512	indomethacin	indomethacin	RedPharm Drug, Inc.	ANDA	Current
68071-4091	indomethacin	indomethacin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68382-293	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-293	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-293	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-294	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-294	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-294	indomethacin	indomethacin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1004	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
70771-1004	indomethacin	indomethacin	Zydus Lifesciences Limited	ANDA	Current
70771-1004	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
70771-1004	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
70771-1005	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
70771-1005	indomethacin	indomethacin	Zydus Lifesciences Limited	ANDA	Current
70771-1005	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
70771-1005	indomethacin	indomethacin	Cadila Healthcare Limited	ANDA	Current
72578-038	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-038	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-038	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-038	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-038	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-039	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-039	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-039	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-039	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current
72578-039	Indomethacin	Indomethacin	Viona Pharmaceuticals Inc	ANDA	Current