Application 211355

Type: ANDA
Sponsor: SOFGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	CAPSULE;ORAL	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211355-001	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB		2019-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211355-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211355-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2019-07-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211355-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211355-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211355-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211355-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211355-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211355-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211355-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211355-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211355-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211355-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211355-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211355-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211355-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211355-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211355-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211355-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211355-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211355-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211355-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211355-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211355-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211355-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211355-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211355-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211355-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211355-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211355-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211355-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211355-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211355-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211355-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211355-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211355-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211355-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211355-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211355-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211355-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211355-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211355-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211355-001	AB	1	`cb3db0bc1861…`

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
omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Chartwell RX, LLC	331d5d9d-58d8-4b4f-8114-b28efa7276d7	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211355 application number: ANDA211355

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-410	Omega-3-Acid Ethyl Esters	Omega-3-Acid Ethyl Esters	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-410	Omega-3-Acid Ethyl Esters	Omega-3-Acid Ethyl Esters	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-410	Omega-3-Acid Ethyl Esters	Omega-3-Acid Ethyl Esters	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-410	Omega-3-Acid Ethyl Esters	Omega-3-Acid Ethyl Esters	ANI Pharmaceuticals, Inc.	ANDA	Current