Application 210093

Type: ANDA
Sponsor: PURACAP PHARM LLC

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
A210093-001	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		2020-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210093-001	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.

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	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210093-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	AB	2020-06-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210093-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210093-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210093-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210093-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210093-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210093-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210093-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210093-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210093-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210093-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210093-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210093-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210093-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210093-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210093-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210093-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210093-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210093-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210093-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210093-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210093-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210093-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210093-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210093-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210093-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210093-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210093-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210093-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210093-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210093-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210093-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210093-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210093-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210093-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210093-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210093-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210093-001	AB	1	`a50c72e98297…`

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
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	REMEDYREPACK INC.	c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093 ndc (product): 70518-3040
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	6fea8860-3c63-435f-a5b0-4281364ebd09	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	4eef8b47-8185-4d93-9b2a-1200b953a6e3	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	52d4fc86-227a-4a74-9f42-50fd184714d8	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	EPIC PHARMA, LLC	787f9929-ef31-42a7-a305-8ba343e39672	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093 ndc (product): 42806-552
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	NCS HealthCare of KY, LLC dba Vangard Labs	c293de7f-b4b6-461b-a0eb-470e5b84618d	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	c8dc6c4a-ed19-4727-ba5a-35075f1ddddf	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210093 application number: ANDA210093 ndc (product): 71335-2024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-552	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	EPIC PHARMA, LLC	ANDA	Current
42806-552	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	EPIC PHARMA, LLC	ANDA	Current
70518-3040	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	REMEDYREPACK INC.	ANDA	Current
70518-3040	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	REMEDYREPACK INC.	ANDA	Current
71335-2024	OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	ANDA	Current