Application 202057

Type: NDA
Sponsor: AMARIN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASCEPA	ICOSAPENT ETHYL	CAPSULE;ORAL	1GM	Yes	Yes
002	VASCEPA	ICOSAPENT ETHYL	CAPSULE;ORAL	500MG	Yes	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
N202057-001	VASCEPA	ICOSAPENT ETHYL	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26
N202057-002	VASCEPA	ICOSAPENT ETHYL	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202057-001	AB
N202057-002	AB

Orange Book patents#

Current patent rows page 1 of 2 · 125 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202057-001	9700537	2027-05-31	U-2707		2020-01-10
N202057-001	9198892	2027-09-25	U-2706		2020-01-10
N202057-001	12171738	2030-02-09	U-4105		2025-01-23
N202057-001	8415335	2030-02-09	U-1287		2013-04-17
N202057-001	8426399	2030-02-09	U-1287
N202057-001	8518929	2030-02-09	U-1287
N202057-001	8524698	2030-02-09	U-1287		2013-09-11
N202057-001	8546372	2030-02-09	U-1287		2013-10-01
N202057-001	8680144	2030-02-09	U-2695		2020-01-06
N202057-001	10010517	2030-04-29	U-2690		2020-01-06
N202057-001	10265287	2030-04-29	U-2700		2020-01-06
N202057-001	10792267	2030-04-29	U-2961		2020-10-16
N202057-001	10842766	2030-04-29	U-2997		2020-12-11
N202057-001	10881632	2030-04-29	U-3052		2021-02-04
N202057-001	11103477	2030-04-29	U-3209		2021-09-21
N202057-001	11154526	2030-04-29	U-3240		2021-11-08
N202057-001	11213504	2030-04-29	U-3292		2022-02-03
N202057-001	11717504	2030-04-29	U-3669		2023-08-18
N202057-001	8298554	2030-04-29		Drug product
N202057-001	8445003	2030-04-29	U-1287
N202057-001	8445013	2030-04-29	U-1287
N202057-001	8454994	2030-04-29	U-2689		2020-01-06
N202057-001	8501225	2030-04-29	U-1287
N202057-001	8563608	2030-04-29	U-1287		2013-10-22
N202057-001	8617593	2030-04-29	U-1478		2014-01-14
N202057-001	8617593	2030-04-29	U-2691		2014-01-14
N202057-001	8617594	2030-04-29	U-1287
N202057-001	8618166	2030-04-29	U-2689		2020-01-06
N202057-001	8623406	2030-04-29	U-1478		2014-01-14
N202057-001	8623406	2030-04-29	U-2692		2014-01-14
N202057-001	8642077	2030-04-29	U-2693		2020-01-06
N202057-001	8691871	2030-04-29	U-2689		2020-01-06
N202057-001	8703185	2030-04-29	U-2691		2020-01-06
N202057-001	8709475	2030-04-29	U-2689		2020-01-06
N202057-001	10842768	2030-06-15	U-2688		2020-12-11
N202057-001	8410086	2030-06-15	U-2688		2020-01-06
N202057-001	8455472	2030-06-15	U-2690		2020-01-06
N202057-001	8669245	2030-06-15	U-2694		2020-01-06
N202057-001	8710041	2030-06-15	U-2690		2020-01-06
N202057-001	10278935	2033-06-28	U-2701		2020-01-06
N202057-001	10278936	2033-06-28	U-2702		2020-01-06
N202057-001	10278937	2033-06-28	U-2703		2020-01-06
N202057-001	10383840	2033-06-28	U-2704		2020-01-06
N202057-001	10555924	2033-06-28	U-2743		2020-02-26
N202057-001	10555925	2033-06-28	U-2744		2020-02-26
N202057-001	10568861	2033-06-28	U-2756		2020-03-20
N202057-001	10576054	2033-06-28	U-2762		2020-03-27
N202057-001	10668042	2033-06-28	U-2841		2020-06-26
N202057-001	10786478	2033-06-28	U-2959		2020-10-16
N202057-001	10786478	2033-06-28	U-2960		2020-10-16
N202057-001	10792270	2033-06-28	U-2962		2020-10-16
N202057-001	10894028	2033-06-28	U-3053		2021-02-04
N202057-001	11000499	2033-06-28	U-3126		2021-06-10
N202057-001	11116742	2033-06-28	U-3221		2021-10-08
N202057-001	11298333	2033-06-28	U-3358		2022-05-11
N202057-001	11369582	2033-06-28	U-2841		2022-07-28
N202057-001	9603826	2033-06-28	U-2696		2020-01-06
N202057-001	9610272	2033-06-28	U-2697		2020-01-06
N202057-001	9623001	2033-06-28	U-2698		2020-01-06
N202057-001	9693984	2033-06-28	U-2697		2020-01-06
N202057-001	9693985	2033-06-28	U-2696		2020-01-06
N202057-001	9693986	2033-06-28	U-2698		2020-01-06
N202057-001	9918954	2033-06-28	U-2699		2020-01-06
N202057-002	9700537	2027-05-31	U-2707		2020-01-10
N202057-002	9198892	2027-09-25	U-2706		2020-01-10
N202057-002	12171738	2030-02-09	U-4105		2025-01-23
N202057-002	8399446	2030-02-09	U-1287		2017-06-26
N202057-002	8415335	2030-02-09	U-1287		2017-06-26
N202057-002	8426399	2030-02-09	U-1287		2017-06-26
N202057-002	8518929	2030-02-09	U-1287		2017-06-26
N202057-002	8524698	2030-02-09	U-1287		2017-06-26
N202057-002	8546372	2030-02-09	U-1287		2017-06-26
N202057-002	8680144	2030-02-09	U-2695		2020-01-06
N202057-002	10010517	2030-04-29	U-2690		2020-01-06
N202057-002	10265287	2030-04-29	U-2700		2020-01-06
N202057-002	10792267	2030-04-29	U-2961		2020-10-16
N202057-002	10842766	2030-04-29	U-2997		2020-12-11
N202057-002	10881632	2030-04-29	U-3052		2021-02-04
N202057-002	11103477	2030-04-29	U-3209		2021-09-21
N202057-002	11154526	2030-04-29	U-3240		2021-11-08

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202057-002	VASCEPA	500MG	CAPSULE / ORAL	AB	RLD	2017-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202057-002	VASCEPA	500MG	CAPSULE / ORAL		RLD	2017-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202057-002	VASCEPA	500MG	CAPSULE / ORAL		RLD	2017-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202057-002	VASCEPA	500MG	CAPSULE / ORAL		RLD	2017-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202057-001	VASCEPA	1GM	CAPSULE / ORAL		RLD, RS	2012-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202057-002	VASCEPA	500MG	CAPSULE / ORAL		RLD	2017-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202057-001	VASCEPA	1GM	CAPSULE / ORAL	AB	RLD, RS	2012-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202057-002	VASCEPA	500MG	CAPSULE / ORAL		RLD	2017-02-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 67 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	N202057-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202057-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202057-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202057-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202057-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202057-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202057-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202057-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202057-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202057-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202057-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202057-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202057-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202057-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202057-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202057-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202057-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202057-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202057-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202057-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202057-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202057-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202057-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202057-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202057-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202057-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202057-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202057-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202057-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202057-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202057-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202057-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202057-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202057-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202057-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202057-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202057-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202057-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202057-002	AB	1	`8869cabd3fbd…`

Observed Orange Book patent history#

Patent history page 1 of 133 · 5,305 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202057-001	9700537	2027-05-31	U-2707		2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	9198892	2027-09-25	U-2706		2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	12171738	2030-02-09	U-4105		2025-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8415335	2030-02-09	U-1287		2013-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8426399	2030-02-09	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8518929	2030-02-09	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8524698	2030-02-09	U-1287		2013-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8546372	2030-02-09	U-1287		2013-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8680144	2030-02-09	U-2695		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10010517	2030-04-29	U-2690		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10265287	2030-04-29	U-2700		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10792267	2030-04-29	U-2961		2020-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10842766	2030-04-29	U-2997		2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10881632	2030-04-29	U-3052		2021-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	11103477	2030-04-29	U-3209		2021-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	11154526	2030-04-29	U-3240		2021-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	11213504	2030-04-29	U-3292		2022-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	11717504	2030-04-29	U-3669		2023-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8298554	2030-04-29		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8445003	2030-04-29	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8445013	2030-04-29	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8454994	2030-04-29	U-2689		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8501225	2030-04-29	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8563608	2030-04-29	U-1287		2013-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8617593	2030-04-29	U-1478		2014-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8617593	2030-04-29	U-2691		2014-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8617594	2030-04-29	U-1287			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8618166	2030-04-29	U-2689		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8623406	2030-04-29	U-2692		2014-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8623406	2030-04-29	U-1478		2014-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8642077	2030-04-29	U-2693		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8691871	2030-04-29	U-2689		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8703185	2030-04-29	U-2691		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8709475	2030-04-29	U-2689		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10842768	2030-06-15	U-2688		2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8410086	2030-06-15	U-2688		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8455472	2030-06-15	U-2690		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8669245	2030-06-15	U-2694		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	8710041	2030-06-15	U-2690		2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202057-001	10278935	2033-06-28	U-2701		2020-01-06	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202057-001	I-819	2022-12-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202057-002	I-819	2022-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202057-001	I-819	2022-12-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202057-002	I-819	2022-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202057-001	I-819	2022-12-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202057-002	I-819	2022-12-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202057-001	I-819	2022-12-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202057-002	I-819	2022-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202057-001	I-819	2022-12-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202057-002	I-819	2022-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202057-001	I-819	2022-12-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202057-002	I-819	2022-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202057-001	I-819	2022-12-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202057-002	I-819	2022-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202057-001	I-819	2022-12-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202057-002	I-819	2022-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202057-001	I-819	2022-12-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202057-002	I-819	2022-12-13	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N202057-001	I-819	2022-12-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N202057-002	I-819	2022-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202057-001	I-819	2022-12-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202057-002	I-819	2022-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202057-001	I-819	2022-12-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N202057-002	I-819	2022-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202057-001	I-819	2022-12-13	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N202057-002	I-819	2022-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202057-001	I-819	2022-12-13	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202057-002	I-819	2022-12-13	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vascepa	ICOSAPENT ETHYL	Bryant Ranch Prepack	d245ddab-d81b-44bd-90d7-0e4d446d9bf5	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202057 application number: NDA202057 ndc (product): 63629-8247
Vascepa	ICOSAPENT ETHYL	Amarin Pharma Inc.	9c1a2828-1583-4414-ab22-a60480e8e508	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202057 application number: NDA202057 ndc (product): 52937-001 ndc (product): 52937-101 ndc (product): 52937-003

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
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-001	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-003	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
52937-101	Vascepa	icosapent ethyl	Amarin Pharma Inc.	NDA	Current
63629-8247	Vascepa	icosapent ethyl	Bryant Ranch Prepack	NDA	Current
63629-8247	Vascepa	icosapent ethyl	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61327	SUPPL	2019-12-17
61277	SUPPL	2019-12-16
47263	SUPPL	2017-02-17
40106	SUPPL	2015-06-24
40104	SUPPL	2014-02-14
32162	SUPPL	2014-02-14
32163	SUPPL	2013-11-27
40105	SUPPL	2013-11-26
40103	SUPPL	2013-03-26
44841	ORIG	2013-03-06
43379	ORIG	2013-03-06
32161	SUPPL	2013-02-04
32160	ORIG	2012-07-30
19048	ORIG	2012-07-30