Application 075074

Type: ANDA
Sponsor: TARO PHARM INDS

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	Yes

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
A075074-001	ETODOLAC	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11
A075074-002	ETODOLAC	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075074-001	AB
A075074-002	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075074-001	ETODOLAC	400MG	TABLET / ORAL	AB		1998-03-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075074-002	ETODOLAC	500MG	TABLET / ORAL	AB	RS	2000-04-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A075074-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075074-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075074-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075074-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075074-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075074-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075074-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075074-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075074-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075074-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075074-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075074-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075074-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075074-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075074-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075074-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075074-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075074-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075074-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075074-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075074-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075074-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075074-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075074-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075074-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075074-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075074-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075074-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075074-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075074-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075074-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075074-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075074-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075074-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075074-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075074-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075074-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075074-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075074-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075074-002	AB	1	`f41ea6bd6efb…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	REMEDYREPACK INC.	188cdd2e-4196-458c-9631-4fa9a0d309b8	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Bryant Ranch Prepack	03458123-e27c-4447-9ef3-3bd32481cb97	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 71335-1958
Etodolac	ETODOLAC	Golden State Medical Supply, Inc.	cf17926c-ed90-4fd0-80af-ccee084075e8	2026-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 60429-312 ndc (product): 60429-311
Etodolac	ETODOLAC	Sun Pharmaceutical Industries, Inc.	ec82b108-6a6f-4d1b-82cb-831d4ed36c80	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 51672-4036 ndc (product): 51672-4018
Etodolac	ETODOLAC	Preferred Pharmaceuticals Inc.	117b3005-a8ec-4f76-824c-95ec42dc87a1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Advanced Rx of Tennessee, LLC	3d865ff0-fc45-1e95-e063-6294a90a8e18	2025-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	A-S Medication Solutions	a7d91fcf-7928-4c9e-862b-6922d6e47c9d	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074 ndc (product): 50090-0592
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	2425aef0-57eb-d1a5-e063-6294a90a0bf2	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1547f132-0d35-45cb-e063-6294a90a2efe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	1149072a-280a-2b11-e063-6394a90ac107	2024-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074
Etodolac	ETODOLAC	Aphena Pharma Solutions - Tennessee, LLC	420b1ed5-e9f2-43dd-8d3c-ca9896221aca	2024-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075074 application number: ANDA075074

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-862	Etodolac	Etodolac	Blenheim Pharmacal, Inc.	ANDA	Current
21695-050	Etodolac	Etodolac	Rebel Distributors Corp	ANDA	Current
35356-711	Etodolac	Etodolac	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-711	Etodolac	Etodolac	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-711	Etodolac	Etodolac	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
35356-711	Etodolac	Etodolac	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
43353-749	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-749	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-752	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-752	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0591	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-0592	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
51655-165	Etodolac	Etodolac	Northwind Pharmaceuticals, LLC	ANDA	Current
51672-4018	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4018	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4018	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4018	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4036	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4036	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4036	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4036	Etodolac	Etodolac	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55700-057	Etodolac	Etodolac	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-311	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
60429-312	Etodolac	Etodolac	Golden State Medical Supply, Inc.	ANDA	Current
61919-092	ETODOLAC	ETODOLAC	DIRECT RX	ANDA	Current
61919-092	ETODOLAC	ETODOLAC	DIRECT RX	ANDA	Current
68788-9929	Etodolac	Etodolac	Preferred Pharmaceuticals, Inc.	ANDA	Current
69036-503	LODINE	etodolac	Sallus Laboratories, LLC	ANDA	Current
71335-1958	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22413	ORIG	1998-03-11