Application 202834

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FYCOMPA	PERAMPANEL	TABLET;ORAL	2MG	Yes	No
002	FYCOMPA	PERAMPANEL	TABLET;ORAL	4MG	Yes	No
003	FYCOMPA	PERAMPANEL	TABLET;ORAL	6MG	Yes	No
004	FYCOMPA	PERAMPANEL	TABLET;ORAL	8MG	Yes	No
005	FYCOMPA	PERAMPANEL	TABLET;ORAL	10MG	Yes	No
006	FYCOMPA	PERAMPANEL	TABLET;ORAL	12MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202834-001	FYCOMPA	PERAMPANEL	2MG	TABLET / ORAL	AB	RLD	2012-10-22
N202834-002	FYCOMPA	PERAMPANEL	4MG	TABLET / ORAL	AB	RLD	2012-10-22
N202834-003	FYCOMPA	PERAMPANEL	6MG	TABLET / ORAL	AB	RLD	2012-10-22
N202834-004	FYCOMPA	PERAMPANEL	8MG	TABLET / ORAL	AB	RLD	2012-10-22
N202834-005	FYCOMPA	PERAMPANEL	10MG	TABLET / ORAL	AB	RLD	2012-10-22
N202834-006	FYCOMPA	PERAMPANEL	12MG	TABLET / ORAL	AB	RLD, RS	2012-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N202834-001	AB
N202834-002	AB
N202834-003	AB
N202834-004	AB
N202834-005	AB
N202834-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N202834-001	8772497	2026-07-01	Drug substance	2014-08-06
N202834-002	8772497	2026-07-01	Drug substance	2014-08-06
N202834-003	8772497	2026-07-01	Drug substance	2014-08-06
N202834-004	8772497	2026-07-01	Drug substance	2014-08-06
N202834-005	8772497	2026-07-01	Drug substance	2014-08-06
N202834-006	8772497	2026-07-01	Drug substance	2014-08-06

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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	N202834-001	FYCOMPA	2MG	TABLET / ORAL	AB	RLD	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-002	FYCOMPA	4MG	TABLET / ORAL	AB	RLD	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-003	FYCOMPA	6MG	TABLET / ORAL	AB	RLD	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-004	FYCOMPA	8MG	TABLET / ORAL	AB	RLD	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-005	FYCOMPA	10MG	TABLET / ORAL	AB	RLD	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-006	FYCOMPA	12MG	TABLET / ORAL	AB	RLD, RS	2012-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	FYCOMPA	2MG	TABLET / ORAL	AB	RLD	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	FYCOMPA	4MG	TABLET / ORAL	AB	RLD	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	FYCOMPA	6MG	TABLET / ORAL	AB	RLD	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	FYCOMPA	8MG	TABLET / ORAL	AB	RLD	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	FYCOMPA	10MG	TABLET / ORAL	AB	RLD	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	FYCOMPA	12MG	TABLET / ORAL	AB	RLD, RS	2012-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202834-001	FYCOMPA	2MG	TABLET / ORAL	AB	RLD	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-002	FYCOMPA	4MG	TABLET / ORAL	AB	RLD	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-003	FYCOMPA	6MG	TABLET / ORAL	AB	RLD	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-004	FYCOMPA	8MG	TABLET / ORAL	AB	RLD	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-005	FYCOMPA	10MG	TABLET / ORAL	AB	RLD	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-006	FYCOMPA	12MG	TABLET / ORAL	AB	RLD, RS	2012-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-001	FYCOMPA	2MG	TABLET / ORAL		RLD	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-002	FYCOMPA	4MG	TABLET / ORAL		RLD	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-003	FYCOMPA	6MG	TABLET / ORAL		RLD	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-004	FYCOMPA	8MG	TABLET / ORAL		RLD	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-005	FYCOMPA	10MG	TABLET / ORAL		RLD	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202834-006	FYCOMPA	12MG	TABLET / ORAL		RLD, RS	2012-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-001	FYCOMPA	2MG	TABLET / ORAL		RLD	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-002	FYCOMPA	4MG	TABLET / ORAL		RLD	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-003	FYCOMPA	6MG	TABLET / ORAL		RLD	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-004	FYCOMPA	8MG	TABLET / ORAL		RLD	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-005	FYCOMPA	10MG	TABLET / ORAL		RLD	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202834-006	FYCOMPA	12MG	TABLET / ORAL		RLD, RS	2012-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-001	FYCOMPA	2MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-002	FYCOMPA	4MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-003	FYCOMPA	6MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-004	FYCOMPA	8MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-005	FYCOMPA	10MG	TABLET / ORAL		RLD	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202834-006	FYCOMPA	12MG	TABLET / ORAL		RLD, RS	2012-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-001	FYCOMPA	2MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-002	FYCOMPA	4MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-003	FYCOMPA	6MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202834-004	FYCOMPA	8MG	TABLET / ORAL		RLD	2012-10-22	`2680178bc6a6…`

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	N202834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202834-006	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202834-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,416 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202834-001	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-002	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-003	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-004	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-005	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202834-006	8772497	2026-07-01		Drug substance	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	6949571	2025-05-23	U-2428	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-001	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	6949571	2025-05-23	U-2428	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-002	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	6949571	2025-05-23	U-2428	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-003	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	6949571	2025-05-23	U-2428	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-004	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	6949571	2025-05-23	U-2428	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-005	8772497	2026-07-01		Drug substance	2014-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	6949571	2025-05-23	U-2088	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	6949571	2025-05-23	U-2089	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	6949571	2025-05-23	U-106	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202834-006	6949571	2025-05-23	U-2429	Drug substance, Drug product	2012-11-19	`31067a03dcf5…`

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): 202834 application number: NDA202834
Fycompa	PERAMPANEL	Eisai Inc.	71cf3309-e182-473c-8b0b-280cabd0e122	2022-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202834 application number: NDA202834 ndc (product): 62856-274 ndc (product): 62856-280 ndc (product): 62856-276 ndc (product): 62856-278 ndc (product): 62856-272 ndc (product): 62856-282

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-272	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-274	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-276	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-278	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-280	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current
62856-282	Fycompa	perampanel	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77585	SUPPL	2024-02-20
76749	SUPPL	2024-02-20
75969	SUPPL	2023-10-27
75961	SUPPL	2023-10-27
58950	SUPPL	2019-06-04
58904	SUPPL	2019-05-31
58903	SUPPL	2019-05-31
55803	SUPPL	2018-10-03
55800	SUPPL	2018-10-03
55763	SUPPL	2018-10-01
49134	SUPPL	2017-07-28
49131	SUPPL	2017-07-28
49105	SUPPL	2017-07-28
45828	SUPPL	2016-11-08
45824	SUPPL	2016-11-07
32323	SUPPL	2015-06-24
19391	SUPPL	2015-06-23
19392	SUPPL	2014-11-20
32324	SUPPL	2014-11-17
32322	SUPPL	2014-02-26
19390	SUPPL	2014-02-19
10122	SUPPL	2014-02-19
19389	SUPPL	2013-07-11
10121	SUPPL	2013-07-03
22900	ORIG	2012-11-28
40231	ORIG	2012-10-26
10120	ORIG	2012-10-26
63234	SUPPL	1900-01-01
63233	SUPPL	1900-01-01
63232	SUPPL	1900-01-01
63223	SUPPL	1900-01-01
63222	SUPPL	1900-01-01
63221	SUPPL	1900-01-01
63220	SUPPL	1900-01-01
52950	SUPPL	1900-01-01
52949	SUPPL	1900-01-01
52948	SUPPL	1900-01-01
52947	SUPPL	1900-01-01
51562	ORIG	1900-01-01
51561	ORIG	1900-01-01
51559	ORIG	1900-01-01
51465	SUPPL	1900-01-01
51464	SUPPL	1900-01-01