Application 212263

Type: ANDA
Sponsor: BAYSHORE PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No
002	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
003	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212263-001	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24
A212263-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24
A212263-003	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212263-001	AB
A212263-002	AB
A212263-003	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 · 114 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
2026-09-14 22:38:34	2026-08	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212263-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212263-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212263-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212263-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212263-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212263-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212263-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212263-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212263-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212263-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212263-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212263-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212263-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212263-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212263-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212263-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212263-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212263-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212263-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212263-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212263-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212263-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212263-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212263-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212263-001	AB	1	`301d65b070ca…`

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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Etodolac	ETODOLAC	A-S Medication Solutions	4d392c1b-95c2-4925-98bf-0203c412d3da	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Northwind Health Company, LLC	7ec87ffd-057e-420c-b8f2-0a6eed4152be	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Northwind Health Company, LLC	b0880f39-a6fa-23ab-e053-2995a90a7eb2	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Northwind Health Company, LLC	da34581d-3066-711c-e053-2995a90a8e84	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	ANI Pharmaceuticals, Inc.	420c7b62-3bea-4d6b-82e0-ab1c176c7f1e	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Edenbridge Pharmaceuticals LLC.	bf1afcd5-e1da-4874-981f-f252cb0b32c2	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	PD-Rx Pharmaceuticals, Inc.	80e9d756-9278-48bb-bfdd-7d070ae0f341	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Chartwell RX, LLC	f86d2b22-d3f7-49cd-98f6-cdb2bd855192	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Unichem Pharmaceuticals (USA), Inc.	18215cb7-c833-4a98-a61d-4bedf518a380	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	479bce92-2066-46ed-b4bb-8c7a59edfffd	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	5e94a98f-d36e-4f28-b79c-6ad8a6793381	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Apotex Corp.	4d682f98-1e8a-4c2b-6df3-169d2ed10dc1	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Advanced Rx of Tennessee, LLC	3d865ff0-fc45-1e95-e063-6294a90a8e18	2025-08-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	NORTHSTAR RX LLC	107ea9d7-80a9-41a4-b61e-168370127319	2025-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	556a7d5f-2c3c-4efb-ac0c-fca140791602	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	a7d91fcf-7928-4c9e-862b-6922d6e47c9d	2025-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.