Application 075419

Type: ANDA
Sponsor: APOTEX

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 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
A075419-001	ETODOLAC	ETODOLAC	200MG	CAPSULE / ORAL	AB		2000-07-28
A075419-002	ETODOLAC	ETODOLAC	300MG	CAPSULE / ORAL	AB		2000-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075419-001	AB
A075419-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075419-001	ETODOLAC	200MG	CAPSULE / ORAL	AB	2000-07-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075419-002	ETODOLAC	300MG	CAPSULE / ORAL	AB	2000-07-28	`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	A075419-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075419-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075419-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075419-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075419-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075419-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075419-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075419-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075419-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075419-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075419-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075419-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075419-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075419-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075419-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075419-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075419-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075419-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075419-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075419-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075419-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A075419-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075419-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A075419-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075419-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075419-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075419-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075419-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075419-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075419-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075419-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075419-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075419-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A075419-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075419-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A075419-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075419-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075419-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075419-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A075419-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etodolac	ETODOLAC	Northwind Health Company, LLC	7ec87ffd-057e-420c-b8f2-0a6eed4152be	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075419 application number: ANDA075419 ndc (product): 51655-166

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-404	Etodolac	Etodolac	AvKARE, Inc.	ANDA	Current
42291-404	Etodolac	Etodolac	AvKARE	ANDA	Current
42291-405	Etodolac	Etodolac	AvKARE, Inc.	ANDA	Current
42291-405	Etodolac	Etodolac	AvKARE	ANDA	Current
43353-294	Etodolac	Etodolac	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-0613	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-0613	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
50090-0613	Etodolac	Etodolac	A-S Medication Solutions	ANDA	Current
51655-166	ETODOLAC	ETODOLAC	Northwind Pharmaceuticals, LLC	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0039	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
60505-0040	Etodolac	Etodolac	Apotex Corp.	ANDA	Current
66267-575	Etodolac	Etodolac	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-575	Etodolac	Etodolac	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8663	ORIG	2000-07-28