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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac ER	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d294d541-3049-6bfe-e053-2995a90a23ea	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETODOLAC
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	d83d9f30-c367-f8b3-e053-2a95a90a1f40	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	c18497e2-9fca-4500-e053-2a95a90a1bcc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac ER	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	baebdfb2-17f6-9081-e053-2a95a90ab331	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETODOLAC
Etodolac	ETODOLAC	NuCare Pharmaceuticals, Inc.	27e98e6d-9fad-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Zydus Lifesciences Limited	0c5f8631-f013-4bbb-b610-0a8a1311844e	2024-11-28		Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	2425aef0-57eb-d1a5-e063-6294a90a0bf2	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	1e4824cc-4d52-4f20-9674-cfcb9ee66574	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Proficient Rx LP	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Zydus Pharmaceuticals USA Inc.	7ef79e43-0628-4795-937e-ebb752d79133	2024-09-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	be53bc5c-4294-44a7-b28c-7db3f925396d	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	b7f7c4a4-6245-43e1-af40-fcf61abbc64e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	dbaa1202-1ade-4471-96fb-4b951b386234	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Amneal Pharmaceuticals NY LLC	2f306e69-c109-4e60-aaf3-9016a4e2cc33	2024-07-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Teva Pharmaceuticals USA, Inc.	f3bf1675-8fda-40d3-8427-0a6a6133a3d3	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	4b0d1245-8d01-4fff-9783-cb30c17d9246	2024-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	15d6bc8e-1e25-6676-e063-6294a90a0035	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Bryant Ranch Prepack	53160db5-ba48-4cac-afbe-acd608daa0dc	2024-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1547f132-0d35-45cb-e063-6294a90a2efe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Etodolac generic name: ETODOLAC
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	141be3f6-198d-ce46-e063-6294a90a7993	2024-03-20	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.