Application 074903

Type: ANDA
Sponsor: SANDOZ

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 43.

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
A074903-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		1997-04-11
A074903-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB		1999-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074903-001	AB
A074903-002	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 · 86 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	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074903-001	ETODOLAC	400MG	TABLET / ORAL	AB	1997-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074903-002	ETODOLAC	500MG	TABLET / ORAL	AB	1999-04-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A074903-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074903-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074903-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074903-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074903-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074903-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074903-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074903-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074903-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074903-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074903-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074903-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074903-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074903-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074903-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074903-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074903-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074903-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074903-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074903-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074903-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074903-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074903-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074903-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074903-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074903-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074903-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074903-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074903-002	AB	1	`74a2ff9319b5…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0675	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0675	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0675	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0675	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0687	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0687	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0687	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
0185-0687	Etodolac	Etodolac	Eon Labs, Inc.	ANDA	Current
43063-834	Etodolac	Etodolac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-834	Etodolac	Etodolac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-834	Etodolac	Etodolac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-834	Etodolac	Etodolac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-7128	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-7128	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
68788-7068	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7068	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7068	Etodolac	Etodolac	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9990	Etodolac	Etodolac	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-346	Etodolac	Etodolac	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-346	Etodolac	Etodolac	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0602	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0602	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0602	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0640	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
71335-0640	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current