Application 091018

Type: ANDA
Sponsor: PAR PHARM INC

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
A091018-001	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			2014-06-24

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091018-001	OMEGA-3-ACID ETHYL ESTERS	1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS	CAPSULE / ORAL	2014-06-24	`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 2 · 25 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	Strides Pharma Science Limited	9499c40e-6665-4fbf-914d-1a9931b93562	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	Major Pharmaceuticals	e40d55f2-db9f-4a48-8639-9aa7491e4de5	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Camber Pharmaceuticals, Inc.	0d842966-26bc-4521-b401-635a83618012	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	XLCare Pharmaceuticals, Inc.	18947318-31b4-42fb-83be-8f1bfe732e95	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	REMEDYREPACK INC.	c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-Acid Ethyl Esters	OMEGA-3-ACID ETHYL ESTERS	Golden State Medical Supply, Inc.	11d744aa-cc06-1206-e063-6294a90a49c9	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Omega-3-Acid Ethyl Esters generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	Lifestar Pharma LLC	769ad170-5d70-4a54-995a-fef95ef503eb	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
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	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
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	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Chartwell RX, LLC	331d5d9d-58d8-4b4f-8114-b28efa7276d7	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	American Health Packaging	294ee73f-849c-4c3d-a415-d66138c91f53	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-Acid Ethyl Esters	OMEGA-3-ACID ETHYL ESTERS	KD Pharma USA, Inc.	d1fd2a28-befb-4a09-b516-0c01bc4c8c6c	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Omega-3-Acid Ethyl Esters generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	KD Pharma USA, Inc.	5cf3091e-4a88-4799-a88a-d53a5bc1de57	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
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	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	EPIC PHARMA, LLC	787f9929-ef31-42a7-a305-8ba343e39672	2025-01-07	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	7d75287f-6f09-43b0-9b38-150685236d47	2024-12-27	Warnings, Adverse reactions	Name fallback brand name: Omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
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	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS	OMEGA-3-ACID ETHYL ESTERS	Bryant Ranch Prepack	c8dc6c4a-ed19-4727-ba5a-35075f1ddddf	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: OMEGA-3-ACID ETHYL ESTERS generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa	2024-02-18	Warnings, Adverse reactions	Name fallback brand name: Omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters	OMEGA-3-ACID ETHYL ESTERS	A-S Medication Solutions	b11807f8-4301-4f91-8a7a-53226f945c49	2024-01-21	Warnings, Adverse reactions	Name fallback brand name: Omega-3-acid ethyl esters generic name: OMEGA-3-ACID ETHYL ESTERS

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-019	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Par Pharmaceutical, Inc.	ANDA	Current
49884-019	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Par Pharmaceutical, Inc.	ANDA	Current
50090-3956	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	A-S Medication Solutions	ANDA	Current
50090-3956	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	A-S Medication Solutions	ANDA	Current
50090-3957	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	A-S Medication Solutions	ANDA	Current
60429-912	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Golden State Medical Supply, Inc.	ANDA	Current
60429-912	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Golden State Medical Supply, Inc.	ANDA	Current
63629-6805	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Bryant Ranch Prepack	ANDA	Current
63629-6805	Omega-3-Acid Ethyl Esters	omega-3-acid ethyl esters	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50612	ORIG	2017-12-06