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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Medsource Pharmaceuticals	12f0685b-2127-d0d6-e063-6394a90a62d1	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	113558e6-8b45-cdbd-e063-6394a90ac036	2024-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1149072a-280a-2b11-e063-6394a90ac107	2024-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	420b1ed5-e9f2-43dd-8d3c-ca9896221aca	2024-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	06f602d1-6faf-41c8-bcfd-33e51f4ca636	2023-10-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	e2fef939-2f4a-46ae-8177-073f5e8f57f5	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	31a55fb1-9721-4202-af7d-f06074b03102	2023-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	A-S Medication Solutions	74baa6ad-b517-48e2-8cef-d77f5755b279	2023-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	0fce1aea-5de2-4acb-8a21-2b775c4adb25	2023-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	0c783997-6f2a-45ae-b899-c060c8be468a	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Doc Rx	cdde46e5-1123-410f-aafc-0c6e904a5d5b	2021-09-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	4712e069-83b6-4052-8d95-f59ab1dba744	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	449b273a-936a-4c49-b0c8-d0daa47733ae	2019-11-01	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.