Application 208834

Type: ANDA
Sponsor: AMNEAL PHARMS CO

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
A208834-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		2018-06-07
A208834-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		2018-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208834-001	AB
A208834-002	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 · 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	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	ETODOLAC	400MG	TABLET / ORAL	AB	2018-06-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	ETODOLAC	500MG	TABLET / ORAL	AB	2018-06-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208834-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208834-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208834-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208834-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208834-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208834-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208834-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208834-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208834-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208834-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208834-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208834-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208834-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208834-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208834-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208834-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208834-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208834-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208834-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208834-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208834-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208834-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208834-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208834-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208834-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208834-002	AB	1	`bb7c543d1eb4…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	55ae2e78-d803-496b-b66d-af1140312785	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 68788-7315
Etodolac	ETODOLAC	A-S Medication Solutions	336d5331-4d60-42e2-8cfc-aad57c01eda0	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 50090-4053
Etodolac	ETODOLAC	A-S Medication Solutions	00125d63-d8d0-46c5-bdf1-80d2c85eda5a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 50090-3963
Etodolac	ETODOLAC	Northwind Health Company, LLC	b0880f39-a6fa-23ab-e053-2995a90a7eb2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 51655-423
Etodolac	ETODOLAC	Northwind Health Company, LLC	da34581d-3066-711c-e053-2995a90a8e84	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	c18497e2-9fca-4500-e053-2a95a90a1bcc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 80425-0140
Etodolac	ETODOLAC	Amneal Pharmaceuticals NY LLC	2f306e69-c109-4e60-aaf3-9016a4e2cc33	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 69238-1342 ndc (product): 69238-1343
Etodolac	ETODOLAC	Bryant Ranch Prepack	4b0d1245-8d01-4fff-9783-cb30c17d9246	2024-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 71335-1230
Etodolac	ETODOLAC	Bryant Ranch Prepack	53160db5-ba48-4cac-afbe-acd608daa0dc	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 71335-0982
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	113558e6-8b45-cdbd-e063-6394a90ac036	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834
Etodolac	ETODOLAC	A-S Medication Solutions	31a55fb1-9721-4202-af7d-f06074b03102	2023-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 50090-3974
Etodolac	ETODOLAC	Doc Rx	cdde46e5-1123-410f-aafc-0c6e904a5d5b	2021-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208834 application number: ANDA208834 ndc (product): 69306-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3963	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3963	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3963	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3963	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3974	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3974	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3974	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-3974	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-4053	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-4053	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
51655-423	Etodolac	Etodolac	Northwind Pharmaceuticals	ANDA	Current
51655-423	Etodolac	Etodolac	Northwind Pharmaceuticals	ANDA	Current
68788-7300	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7300	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7300	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7300	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7300	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7315	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7315	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7315	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7315	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1342	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1343	Etodolac	Etodolac	Amneal Pharmaceuticals NY LLC	ANDA	Current
69306-020	Etodolac	Etodolac	Doc Rx	ANDA	Current
69306-020	Etodolac	Etodolac	Doc Rx	ANDA	Current
69306-020	Etodolac	Etodolac	Doc Rx	ANDA	Current
69306-020	Etodolac	Etodolac	Doc Rx	ANDA	Current
70518-3163	Etodolac	Etodolac	REMEDYREPACK INC.	ANDA	Current
71335-0982	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0982	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0982	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-1230	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-1230	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
80425-0140	Lodine	Etodolac 400mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0140	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0140	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0140	Etodolac	Etodolac	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current