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

NDC Listings For This Application#

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

Application 206947

Related Records#

Application Products#

NDC Listings For This Application#

Documents#