Application 075126

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	CAPSULE;ORAL	200MG	No	No
002	ETODOLAC	ETODOLAC	CAPSULE;ORAL	300MG	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
A075126-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		1999-09-16
A075126-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB		1999-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075126-001	AB
A075126-002	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	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075126-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	1999-09-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075126-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	1999-09-16	`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	A075126-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075126-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075126-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075126-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075126-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075126-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075126-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075126-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075126-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075126-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075126-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075126-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075126-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075126-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075126-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075126-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075126-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075126-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075126-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075126-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075126-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075126-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075126-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075126-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075126-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075126-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075126-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075126-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075126-002	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Bryant Ranch Prepack	301087e4-f05c-4fd3-8815-c86c6f12ff61	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	a355160d-24c3-4a4d-99ea-84c80ce67f90	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126
Etodolac	ETODOLAC	Bryant Ranch Prepack	e7a81661-28a2-40d7-8c90-786629c81e36	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126 ndc (product): 63629-3641
Etodolac	ETODOLAC	A-S Medication Solutions	4d392c1b-95c2-4925-98bf-0203c412d3da	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126 ndc (product): 50090-2132
Etodolac	ETODOLAC	ANI Pharmaceuticals, Inc.	420c7b62-3bea-4d6b-82e0-ab1c176c7f1e	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126 ndc (product): 62559-251 ndc (product): 62559-250
Etodolac	ETODOLAC	Bryant Ranch Prepack	b7f7c4a4-6245-43e1-af40-fcf61abbc64e	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126 ndc (product): 63629-1936
Etodolac	ETODOLAC	Bryant Ranch Prepack	dbaa1202-1ade-4471-96fb-4b951b386234	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126 ndc (product): 63629-1935
Etodolac	ETODOLAC	Proficient Rx LP	0fce1aea-5de2-4acb-8a21-2b775c4adb25	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075126 application number: ANDA075126

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-049	Etodolac	Etodolac	Rebel Distributors Corp	ANDA	Current
50090-2132	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-2132	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
52959-483	ETODOLAC	ETODOLAC	H. J. Harkins Co., Inc	ANDA	Current
62559-250	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-250	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-250	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-251	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-251	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-251	Etodolac	Etodolac	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1935	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1935	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1935	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1936	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1936	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-1936	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-3641	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-3641	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-3641	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
67296-1271	Etodolac	Etodolac	RedPharm Drug, Inc.	ANDA	Current
67296-1271	Etodolac	Etodolac	RedPharm Drug, Inc.	ANDA	Current
67296-1271	Etodolac	Etodolac	RedPharm Drug, Inc.	ANDA	Current
70934-282	Etodolac	Etodolac	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-282	Etodolac	Etodolac	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8529	ORIG	1999-09-16