Application 076004

Type: ANDA
Sponsor: APOTEX INC

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 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
A076004-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2002-12-03
A076004-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2002-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076004-001	AB
A076004-002	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	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	ETODOLAC	400MG	TABLET / ORAL	AB	2002-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	ETODOLAC	500MG	TABLET / ORAL	AB	2002-12-03	`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	A076004-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076004-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076004-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076004-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076004-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076004-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076004-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076004-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076004-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076004-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076004-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076004-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076004-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076004-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076004-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076004-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076004-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076004-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076004-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076004-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076004-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076004-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076004-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076004-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076004-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076004-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076004-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076004-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076004-002	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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Marys Medical Park Pharmacy	60cb4de0-ed88-a46b-e053-2a91aa0a8b6d	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	cad9b5ca-a9d4-41d4-aff2-67d0c458aad6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	007c55fa-ef8b-4a8e-bfe5-e47c6e5da727	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	41bd86b9-2ef3-49a4-874e-fe8ac6891080	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	556eaa67-d30d-4095-a981-c65f98d3acdd	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	REMEDYREPACK INC.	1a38815e-1903-4f03-b83e-9780c71d4971	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	80e9d756-9278-48bb-bfdd-7d070ae0f341	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Bryant Ranch Prepack	479bce92-2066-46ed-b4bb-8c7a59edfffd	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Apotex Corp.	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	556a7d5f-2c3c-4efb-ac0c-fca140791602	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d83d9f30-c367-f8b3-e053-2a95a90a1f40	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004 ndc (product): 80425-0190
Etodolac	ETODOLAC	Bryant Ranch Prepack	be53bc5c-4294-44a7-b28c-7db3f925396d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004 ndc (product): 71335-0126 ndc (product): 71335-0399
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	141be3f6-198d-ce46-e063-6294a90a7993	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Medsource Pharmaceuticals	12f0685b-2127-d0d6-e063-6394a90a62d1	2024-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	e2fef939-2f4a-46ae-8177-073f5e8f57f5	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	A-S Medication Solutions	74baa6ad-b517-48e2-8cef-d77f5755b279	2023-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004
Etodolac	ETODOLAC	Proficient Rx LP	0c783997-6f2a-45ae-b899-c060c8be468a	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076004 application number: ANDA076004 ndc (product): 71205-467

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70859-035	NuDroxiPAK E-400	Etodolac,Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-035	NuDroxiPAK E-400	Etodolac,Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-467	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
71205-467	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
71335-0126	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0126	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0399	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0399	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
80425-0190	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current