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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 926 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	N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	7253286*PED	2026-04-24		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	7612208*PED	2027-03-19		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	9006256	2027-07-27	U-1695		2015-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	9006256*PED	2028-01-27		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12508313	2030-10-04		Drug product	2025-12-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12508313*PED	2031-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	10259791	2035-08-26		Drug substance	2019-05-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	10407393	2035-08-26		Drug substance	2019-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	11186547	2035-08-26		Drug substance	2021-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	11090386	2036-02-23	U-3519		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	10259791*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	10407393*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	11186547*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12083112	2036-03-03	U-3996		2024-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12083112	2036-03-03	U-3997		2024-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	11090386*PED	2036-08-23		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12083112*PED	2036-09-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12226409	2038-05-15	U-4146		2025-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	12226409*PED	2038-11-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	7253286*PED	2026-04-24		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	7612208*PED	2027-03-19		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	9006256	2027-07-27	U-1695		2015-05-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	9006256*PED	2028-01-27		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	12508313	2030-10-04		Drug product	2025-12-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	12508313*PED	2031-04-04		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	10259791	2035-08-26		Drug substance	2019-05-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	10407393	2035-08-26		Drug substance	2019-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	11186547	2035-08-26		Drug substance	2021-12-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	11090386	2036-02-23	U-3519		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	10259791*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	10407393*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	11186547*PED	2036-02-26		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	12083112	2036-03-03	U-3996		2024-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	12083112	2036-03-03	U-3997		2024-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	11090386*PED	2036-08-23		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	12083112*PED	2036-09-03		Pediatric extension		`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 450 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N206947-001	ODE-196	2025-08-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	PED	2026-02-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	M-14	2027-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-001	PED	2027-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	ODE-196	2025-08-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	PED	2026-02-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	M-14	2027-04-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N206947-002	PED	2027-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N206947-001	ODE-196	2025-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	PED	2026-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	M-14	2027-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	PED	2027-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	ODE-196	2025-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	PED	2026-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	M-14	2027-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	PED	2027-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206947-001	ODE-196	2025-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-001	PED	2026-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-001	M-14	2027-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-001	PED	2027-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	ODE-196	2025-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	PED	2026-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	M-14	2027-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	PED	2027-10-03	`caaa826d4ba7…`
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…`

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