Application 075009

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET;ORAL	400MG	No	No
002	ETODOLAC	ETODOLAC	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075009-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL			1997-11-26
A075009-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL			1999-12-28

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 · 84 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
2026-08-18 06:07:40	2026-07	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075009-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075009-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075009-001	ETODOLAC	400MG	TABLET / ORAL		1997-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075009-002	ETODOLAC	500MG	TABLET / ORAL		1999-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075009-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075009-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075009-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075009-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075009-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075009-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075009-002	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 1 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Aurobindo Pharma Limited	c74c3c56-a5ac-40b4-974b-c4f4b05c5df9	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Sun Pharmaceutical Industries, Inc.	ec82b108-6a6f-4d1b-82cb-831d4ed36c80	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	TaSun Pharmaceutical Industries, Inc.	2c5b44b4-78d5-43b2-827d-d2763b6672b3	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	St. Marys Medical Park Pharmacy	60cb4de0-ed88-a46b-e053-2a91aa0a8b6d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	REMEDYREPACK INC.	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	007c55fa-ef8b-4a8e-bfe5-e47c6e5da727	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	St. Mary's Medical Park Pharmacy	6761e6b1-2399-4643-e053-2991aa0a6f17	2026-05-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	41bd86b9-2ef3-49a4-874e-fe8ac6891080	2026-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	556eaa67-d30d-4095-a981-c65f98d3acdd	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	117b3005-a8ec-4f76-824c-95ec42dc87a1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	55ae2e78-d803-496b-b66d-af1140312785	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	ea12933b-2280-4a11-a0e3-554194c53c4d	2026-03-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	301087e4-f05c-4fd3-8815-c86c6f12ff61	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	a355160d-24c3-4a4d-99ea-84c80ce67f90	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	e7a81661-28a2-40d7-8c90-786629c81e36	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	03458123-e27c-4447-9ef3-3bd32481cb97	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
etodolac	ETODOLAC	Ipca Laboratories Limited	f50a93ca-584a-4205-a79b-31bafdd309c2	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: etodolac generic name: ETODOLAC
etodolac	ETODOLAC	Ipca Laboratories Limited	d583988c-3e7e-4415-b2fd-34049791cd1c	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	336d5331-4d60-42e2-8cfc-aad57c01eda0	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	00125d63-d8d0-46c5-bdf1-80d2c85eda5a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0892	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-0892	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1893	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1893	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
33261-043	Etodolac	Etodolac	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-044	Etodolac	Etodolac	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-826	Etodolac	Etodolac	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42254-052	Etodolac	Etodolac	Rebel Distributors Corp	ANDA	Current
52959-471	Etodolac	Etodolac	H.J. Harkins Company, Inc.	ANDA	Current
61919-574	ETODOLAC	ETODOLAC	DIRECT RX	ANDA	Current
63187-796	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63187-796	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63629-1377	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1377	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
66336-878	Etodolac	Etodolac	Dispensing Solutions, Inc.	ANDA	Current
68788-9360	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9928	Etodolac	Etodolac	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0092	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0092	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30733	SUPPL	1999-12-28
30732	SUPPL	1999-12-28
30731	SUPPL	1999-12-28
8487	SUPPL	1999-12-28
8486	SUPPL	1999-12-28