Application 206947

Type: NDA
Sponsor: EISAI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LENVIMA	LENVATINIB MESYLATE	CAPSULE;ORAL	EQ 4MG BASE	Yes	No
002	LENVIMA	LENVATINIB MESYLATE	CAPSULE;ORAL	EQ 10MG BASE	Yes	Yes

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

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
N206947-001	LENVIMA	LENVATINIB MESYLATE	EQ 4MG BASE	CAPSULE / ORAL		RLD	2015-02-13
N206947-002	LENVIMA	LENVATINIB MESYLATE	EQ 10MG BASE	CAPSULE / ORAL		RLD, RS	2015-02-13

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10
N206947-001	7253286*PED	2026-04-24		Pediatric extension
N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10
N206947-001	7612208*PED	2027-03-19		Pediatric extension
N206947-001	9006256	2027-07-27	U-1695		2015-05-12
N206947-001	9006256*PED	2028-01-27		Pediatric extension
N206947-001	12508313	2030-10-04		Drug product	2025-12-30
N206947-001	12508313*PED	2031-04-04		Pediatric extension
N206947-001	10259791	2035-08-26		Drug substance	2019-05-13
N206947-001	10407393	2035-08-26		Drug substance	2019-10-04
N206947-001	11186547	2035-08-26		Drug substance	2021-12-17
N206947-001	11090386	2036-02-23	U-3519		2023-02-10
N206947-001	10259791*PED	2036-02-26		Pediatric extension
N206947-001	10407393*PED	2036-02-26		Pediatric extension
N206947-001	11186547*PED	2036-02-26		Pediatric extension
N206947-001	12083112	2036-03-03	U-3996		2024-10-03
N206947-001	12083112	2036-03-03	U-3997		2024-10-03
N206947-001	11090386*PED	2036-08-23		Pediatric extension
N206947-001	12083112*PED	2036-09-03		Pediatric extension
N206947-001	12226409	2038-05-15	U-4146		2025-03-07
N206947-001	12226409*PED	2038-11-15		Pediatric extension
N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10
N206947-002	7253286*PED	2026-04-24		Pediatric extension
N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10
N206947-002	7612208*PED	2027-03-19		Pediatric extension
N206947-002	9006256	2027-07-27	U-1695		2015-05-12
N206947-002	9006256*PED	2028-01-27		Pediatric extension
N206947-002	12508313	2030-10-04		Drug product	2025-12-30
N206947-002	12508313*PED	2031-04-04		Pediatric extension
N206947-002	10259791	2035-08-26		Drug substance	2019-05-13
N206947-002	10407393	2035-08-26		Drug substance	2019-10-04
N206947-002	11186547	2035-08-26		Drug substance	2021-12-17
N206947-002	11090386	2036-02-23	U-3519		2023-02-10
N206947-002	10259791*PED	2036-02-26		Pediatric extension
N206947-002	10407393*PED	2036-02-26		Pediatric extension
N206947-002	11186547*PED	2036-02-26		Pediatric extension
N206947-002	12083112	2036-03-03	U-3996		2024-10-03
N206947-002	12083112	2036-03-03	U-3997		2024-10-03
N206947-002	11090386*PED	2036-08-23		Pediatric extension
N206947-002	12083112*PED	2036-09-03		Pediatric extension
N206947-002	12226409	2038-05-15	U-4146		2025-03-07
N206947-002	12226409*PED	2038-11-15		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N206947-001	ODE-196	2025-08-15
N206947-001	PED	2026-02-15
N206947-001	M-14	2027-04-03
N206947-001	PED	2027-10-03
N206947-002	ODE-196	2025-08-15
N206947-002	PED	2026-02-15
N206947-002	M-14	2027-04-03
N206947-002	PED	2027-10-03

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 800 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	N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7253286*PED	2026-04-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7612208*PED	2027-03-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	9006256	2027-07-27	U-1695		2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	9006256*PED	2028-01-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12508313	2030-10-04		Drug product	2025-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12508313*PED	2031-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10259791	2035-08-26		Drug substance	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10407393	2035-08-26		Drug substance	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11186547	2035-08-26		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11090386	2036-02-23	U-3519		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10259791*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10407393*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11186547*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112	2036-03-03	U-3996		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112	2036-03-03	U-3997		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11090386*PED	2036-08-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112*PED	2036-09-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12226409	2038-05-15	U-4146		2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12226409*PED	2038-11-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7253286*PED	2026-04-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7612208*PED	2027-03-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	9006256	2027-07-27	U-1695		2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	9006256*PED	2028-01-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12508313	2030-10-04		Drug product	2025-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12508313*PED	2031-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10259791	2035-08-26		Drug substance	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10407393	2035-08-26		Drug substance	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11186547	2035-08-26		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11090386	2036-02-23	U-3519		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10259791*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10407393*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11186547*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112	2036-03-03	U-3996		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112	2036-03-03	U-3997		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11090386*PED	2036-08-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112*PED	2036-09-03		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 426 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206947-001	ODE-196	2025-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	PED	2026-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	M-14	2027-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	PED	2027-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	ODE-196	2025-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	PED	2026-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	M-14	2027-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	PED	2027-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	ODE-196	2025-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	PED	2026-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	M-14	2027-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	PED	2027-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	ODE-196	2025-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	PED	2026-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	M-14	2027-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	PED	2027-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206947-001	ODE-196	2025-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	PED	2026-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	M-14	2027-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	PED	2027-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	ODE-196	2025-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	PED	2026-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	M-14	2027-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	PED	2027-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	ODE-196	2025-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	PED	2026-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	M-14	2027-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	PED	2027-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	ODE-196	2025-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	PED	2026-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	M-14	2027-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	PED	2027-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	ODE-196	2025-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	PED	2026-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	M-14	2027-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	PED	2027-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	ODE-196	2025-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	PED	2026-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	M-14	2027-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	PED	2027-10-03	`b8a1b40f171c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lenvima	LENVATINIB	Eisai Inc.	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206947 application number: NDA206947 ndc (product): 62856-704 ndc (product): 62856-710 ndc (product): 62856-712 ndc (product): 62856-714 ndc (product): 62856-708

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 136 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-704	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-708	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-710	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-712	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current
62856-714	Lenvima	Lenvatinib	Eisai Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81158	SUPPL	2025-02-07
80993	SUPPL	2025-02-05
80270	SUPPL	2024-11-21
80269	SUPPL	2024-11-21
78750	SUPPL	2024-07-02
78749	SUPPL	2024-06-10
78062	SUPPL	2024-04-04
78059	SUPPL	2024-04-03
75919	SUPPL	2023-10-24
75900	SUPPL	2023-10-24
74206	SUPPL	2023-05-10
72613	SUPPL	2022-11-14
72606	SUPPL	2022-11-13
71746	SUPPL	2022-08-08
71738	SUPPL	2022-08-08
69731	SUPPL	2021-12-21
69715	SUPPL	2021-12-21
68340	SUPPL	2021-08-11
68335	SUPPL	2021-08-11
68158	SUPPL	2021-07-22
68154	SUPPL	2021-07-22
65691	SUPPL	2020-12-22
65679	SUPPL	2020-12-22
65194	SUPPL	2020-11-12
65187	SUPPL	2020-11-12
64630	SUPPL	2020-09-21
64582	SUPPL	2020-09-16
62793	SUPPL	2020-05-01
62787	SUPPL	2020-05-01
61998	SUPPL	2020-02-28
61932	SUPPL	2020-02-21
60033	SUPPL	2019-09-18
60023	SUPPL	2019-09-17
56827	SUPPL	2018-12-20
56759	SUPPL	2018-12-17
55181	SUPPL	2018-08-16
55180	SUPPL	2018-08-16
54556	SUPPL	2018-06-14
54491	SUPPL	2018-06-11
49205	SUPPL	2017-08-02
49178	SUPPL	2017-08-01
32838	SUPPL	2016-05-16
19952	SUPPL	2016-05-13
40576	SUPPL	2016-04-29
10604	SUPPL	2016-04-26
43529	ORIG	2015-03-12
24522	ORIG	2015-03-12
32837	ORIG	2015-02-17
19740	ORIG	2015-02-13