Application 075665

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	600MG	No	Yes
002	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
003	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
A075665-001	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31
A075665-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31
A075665-003	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075665-001	AB
A075665-002	AB
A075665-003	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 4 · 126 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	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2000-07-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075665-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075665-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075665-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075665-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075665-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075665-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075665-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075665-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075665-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075665-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075665-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075665-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075665-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075665-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075665-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075665-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075665-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075665-001	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Proficient Rx LP	5a040d8e-8d0c-442f-b4e5-161aa7ccbe9a	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665 ndc (product): 71205-140
Etodolac	ETODOLAC	Teva Pharmaceuticals USA, Inc.	f3bf1675-8fda-40d3-8427-0a6a6133a3d3	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075665 application number: ANDA075665 ndc (product): 0093-1122 ndc (product): 0093-7172 ndc (product): 0093-1118

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1118	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1118	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1118	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1118	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1122	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1122	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1122	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1122	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7172	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7172	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7172	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7172	Etodolac	Etodolac	Teva Pharmaceuticals USA, Inc.	ANDA	Current
66336-586	Etodolac	Etodolac	Dispensing Solutions, Inc.	ANDA	Current
68151-0738	Etodolac	Etodolac	Carilion Materials Management	ANDA	Current
71205-140	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
71205-140	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30982	SUPPL	2001-02-05
30981	SUPPL	2001-02-05
8755	SUPPL	2001-02-05
30980	ORIG	2000-07-31