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 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 884 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7253286*PED	2026-04-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7612208*PED	2027-03-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	9006256	2027-07-27	U-1695		2015-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	9006256*PED	2028-01-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12508313	2030-10-04		Drug product	2025-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12508313*PED	2031-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10259791	2035-08-26		Drug substance	2019-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10407393	2035-08-26		Drug substance	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11186547	2035-08-26		Drug substance	2021-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11090386	2036-02-23	U-3519		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10259791*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10407393*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11186547*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112	2036-03-03	U-3996		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112	2036-03-03	U-3997		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11090386*PED	2036-08-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112*PED	2036-09-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12226409	2038-05-15	U-4146		2025-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12226409*PED	2038-11-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7253286*PED	2026-04-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7612208*PED	2027-03-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	9006256	2027-07-27	U-1695		2015-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	9006256*PED	2028-01-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12508313	2030-10-04		Drug product	2025-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12508313*PED	2031-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10259791	2035-08-26		Drug substance	2019-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10407393	2035-08-26		Drug substance	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11186547	2035-08-26		Drug substance	2021-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11090386	2036-02-23	U-3519		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10259791*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10407393*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11186547*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112	2036-03-03	U-3996		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112	2036-03-03	U-3997		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11090386*PED	2036-08-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112*PED	2036-09-03		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 12 · 442 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-10-29 15:01 UTC	2024-10	N206947-002	I-868	2024-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	M-272	2024-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	ODE-196	2025-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	PED	2026-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	M-14	2027-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	PED	2027-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	M-269	2024-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	I-868	2024-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	M-272	2024-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	ODE-196	2025-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	PED	2026-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	M-14	2027-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	PED	2027-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	M-269	2024-07-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	I-868	2024-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	M-272	2024-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	ODE-196	2025-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	PED	2026-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	M-14	2027-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	PED	2027-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	M-269	2024-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	I-868	2024-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	M-272	2024-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	ODE-196	2025-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	PED	2026-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	M-14	2027-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	PED	2027-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	M-269	2024-07-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	I-868	2024-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	M-272	2024-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	ODE-196	2025-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	PED	2026-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	M-14	2027-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	PED	2027-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	M-269	2024-07-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	I-868	2024-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	M-272	2024-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	ODE-196	2025-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	PED	2026-02-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-002	M-269	2024-07-21	`1e350fbaab3a…`

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 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