Application 075078

Type: ANDA
Sponsor: TARO

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	Yes

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
A075078-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30
A075078-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075078-001	AB
A075078-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075078-001	ETODOLAC	200MG	CAPSULE / ORAL	AB		1998-04-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075078-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	RS	1998-04-30	`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	A075078-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075078-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075078-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075078-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075078-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075078-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075078-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075078-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075078-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075078-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075078-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075078-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075078-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075078-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075078-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075078-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075078-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075078-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075078-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075078-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075078-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075078-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075078-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075078-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075078-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075078-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075078-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075078-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075078-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075078-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075078-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075078-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075078-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075078-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075078-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075078-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075078-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075078-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075078-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075078-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Sun Pharmaceutical Industries, Inc.	ec82b108-6a6f-4d1b-82cb-831d4ed36c80	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075078 application number: ANDA075078 ndc (product): 51672-4017 ndc (product): 51672-4016
Etodolac	ETODOLAC	Bryant Ranch Prepack	ea12933b-2280-4a11-a0e3-554194c53c4d	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075078 application number: ANDA075078
Etodolac	ETODOLAC	Golden State Medical Supply, Inc.	cf17926c-ed90-4fd0-80af-ccee084075e8	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075078 application number: ANDA075078 ndc (product): 60429-243 ndc (product): 60429-244

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-121	Etodolac	etodolac	Rebel Distributors Corp	ANDA	Current
43353-753	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-753	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-918	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-918	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51672-4016	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4016	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4016	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4016	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4017	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4017	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4017	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4017	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55289-501	Etodolac	Etodolac	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-243	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-244	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
68788-9930	Etodolac	Etodolac	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22415	ORIG	1998-04-30