Application 208277

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FYCOMPA	PERAMPANEL	SUSPENSION;ORAL	0.5MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208277-001	FYCOMPA	PERAMPANEL	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208277-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208277-001	8772497	2026-07-01		Drug substance	2016-05-27

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208277-001	FYCOMPA	0.5MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2016-04-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N208277-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208277-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208277-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208277-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208277-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208277-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 239 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208277-001	8772497	2026-07-01		Drug substance	2016-05-27	`2680178bc6a6…`

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
Fycompa	PERAMPANEL	Catalyst Pharmaceuticals, Inc.	ec812ea3-de3a-4271-957c-db8f692d1ae3	2024-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208277 application number: NDA208277
Fycompa	PERAMPANEL	Eisai Inc.	71cf3309-e182-473c-8b0b-280cabd0e122	2022-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208277 application number: NDA208277 ndc (product): 62856-290

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-290	Fycompa	perampanel	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80886	SUPPL	2025-01-21
80885	SUPPL	2025-01-21
74656	SUPPL	2023-06-29
74655	SUPPL	2023-06-29
58951	SUPPL	2019-06-04
58902	SUPPL	2019-05-31
58901	SUPPL	2019-05-31
55802	SUPPL	2018-10-03
55801	SUPPL	2018-10-03
55764	SUPPL	2018-10-01
50485	ORIG	2017-11-27
49133	SUPPL	2017-07-28
49132	SUPPL	2017-07-28
49106	SUPPL	2017-07-28
32903	ORIG	2016-05-06
40631	ORIG	2016-05-03
66470	ORIG	1900-01-01
66469	ORIG	1900-01-01
66468	ORIG	1900-01-01
66467	ORIG	1900-01-01
63224	ORIG	1900-01-01
51558	ORIG	1900-01-01
51557	ORIG	1900-01-01
51556	ORIG	1900-01-01