Application 209457

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	CAPSULE;ORAL	1GM	No	No
002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209457-001	ICOSAPENT ETHYL	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB		2020-05-21
A209457-002	ICOSAPENT ETHYL	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB		2023-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209457-001	AB
A209457-002	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 2 · 62 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	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209457-002	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	2023-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-001	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	2020-05-21	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 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	A209457-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209457-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209457-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209457-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209457-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209457-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209457-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209457-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209457-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209457-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209457-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209457-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209457-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209457-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209457-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209457-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209457-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209457-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209457-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209457-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209457-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209457-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209457-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209457-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209457-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209457-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209457-001	AB	1	`6a51e52b5d6a…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	f9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457 ndc (product): 63629-9311
Icosapent Ethyl	ICOSAPENT ETHYL	Northstar Rx LLC	45f8bb41-bdb1-4afc-83ec-9dc69720ee9c	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457 ndc (product): 72603-129
Icosapent Ethyl	ICOSAPENT ETHYL	Hikma Pharmaceuticals USA Inc.	e3d38d1d-fbe7-413d-849a-675e7dfa9b0a	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457 ndc (product): 0054-0508
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	07631e74-48e5-46ec-b8db-4b1bcf62d283	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	582638e5-9881-409d-a455-041b5ba6892a	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457
Icosapent Ethyl	ICOSAPENT ETHYL	Bryant Ranch Prepack	0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209457 application number: ANDA209457

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
0054-0508	Icosapent Ethyl	Icosapent Ethyl	Hikma Pharmaceuticals USA Inc.	ANDA	Current
63629-9311	Icosapent Ethyl	Icosapent Ethyl	Bryant Ranch Prepack	ANDA	Current
63629-9311	Icosapent Ethyl	Icosapent Ethyl	Bryant Ranch Prepack	ANDA	Current
72603-129	Icosapent Ethyl	Icosapent Ethyl	Northstar Rx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63418	ORIG	2020-06-04