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FDA NDA · NDA206947

LENVIMA

lenvatinib

Sponsor: EISAI INC

APPLICATION
NDA206947
TYPE
NDA
ORIGINAL APPROVAL
2015-02-13
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LENVIMA · ReferencePrescription
LENVATINIB MESYLATE EQ 4MG BASE · CAPSULE · ORAL
LENVIMA · ReferencePrescription
LENVATINIB MESYLATE EQ 10MG BASE · CAPSULE · ORAL

Approval history

2025-01-29Efficacy · Supplement 33 · priority — Label ↗AP
2024-11-20Labeling · Supplement 32 · standard — Label ↗AP
2024-06-07Efficacy · Supplement 31 · standard — Label ↗AP
2024-04-03Efficacy · Supplement 30 · priority — Label ↗AP
2023-10-23Efficacy · Supplement 28 · standard — Letter ↗AP
2022-11-10Labeling · Supplement 24 · standard — Label ↗AP
2022-08-05Labeling · Supplement 25 · standard — Letter ↗AP
2021-12-19Efficacy · Supplement 21 · standard — Letter ↗AP
2021-08-10Efficacy · Supplement 19 · priority — Label ↗AP
2021-07-21Efficacy · Supplement 20 · priority — Label ↗AP
2020-12-18Labeling · Supplement 18 · standard — Letter ↗AP
2020-11-10Labeling · Supplement 16 · standard — Letter ↗AP
2020-09-14Labeling · Supplement 17 · standard — Letter ↗AP
2020-04-23Labeling · Supplement 13 · standard — Label ↗AP
2020-02-20Labeling · Supplement 12 · standard — Letter ↗AP
2019-09-17Efficacy · Supplement 11 · priority — Label ↗AP
2018-12-07Labeling · Supplement 9 · standard — Label ↗AP
2018-08-15Efficacy · Supplement 7 · standard — Label ↗AP
2018-06-06Labeling · Supplement 8 · standard — Label ↗AP
2017-07-31Labeling · Supplement 5 · standard — Label ↗AP
2016-05-13Efficacy · Supplement 3 · priority — Label ↗AP
2016-04-22Labeling · Supplement 4 · standard — Label ↗AP
2015-10-16Manufacturing (CMC) · Supplement 1 · priorityAP
2015-02-13Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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