Application 091134

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	400MG	No	No
002	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
003	ETODOLAC	ETODOLAC	TABLET, EXTENDED RELEASE;ORAL	600MG	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	Approval date
A091134-001	ETODOLAC	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-002	ETODOLAC	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23
A091134-003	ETODOLAC	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091134-001	AB
A091134-002	AB
A091134-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-002	ETODOLAC	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-003	ETODOLAC	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091134-001	ETODOLAC	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2014-01-23	`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	A091134-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091134-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091134-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091134-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091134-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091134-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091134-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091134-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091134-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091134-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091134-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091134-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091134-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091134-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091134-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	St. Mary's Medical Park Pharmacy	6761e6b1-2399-4643-e053-2991aa0a6f17	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 60760-298
Etodolac	ETODOLAC	NuCare Pharmaceuticals, Inc.	27e98e6d-9fad-3a94-e063-6394a90a1dcb	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Zydus Lifesciences Limited	0c5f8631-f013-4bbb-b610-0a8a1311844e	2024-11-28		Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 65841-779 ndc (product): 65841-778 ndc (product): 65841-777
Etodolac	ETODOLAC	Bryant Ranch Prepack	1e4824cc-4d52-4f20-9674-cfcb9ee66574	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 63629-8598
Etodolac	ETODOLAC	Zydus Pharmaceuticals USA Inc.	7ef79e43-0628-4795-937e-ebb752d79133	2024-09-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 68382-272 ndc (product): 68382-271 ndc (product): 68382-273
Etodolac	ETODOLAC	Advanced Rx Pharmacy of Tennessee, LLC	15d6bc8e-1e25-6676-e063-6294a90a0035	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134
Etodolac	ETODOLAC	Proficient Rx LP	4712e069-83b6-4052-8d95-f59ab1dba744	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091134 application number: ANDA091134 ndc (product): 63187-374

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1317	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
52959-649	Etodolac	Etodolac	H.J. HARKINS COMPANY, INC.	ANDA	Current
55700-601	Etodolac	Etodolac	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60760-281	Etodolac	Etodolac	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-298	Etodolac	Etodolac	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-374	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63187-374	Etodolac	Etodolac	Proficient Rx LP	ANDA	Current
63629-8598	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
63629-8598	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current
65841-777	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-777	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-778	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Zydus Lifesciences Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
65841-779	Etodolac	Etodolac	Cadila Healthcare Limited	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-271	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-272	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-273	Etodolac	Etodolac	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70332-320	Etodolac	Etodolac	California Pharmaceuticals, LLC	ANDA	Current
71335-0183	Etodolac	Etodolac	Bryant Ranch Prepack	ANDA	Current