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FDA NDA · NDA201532

HALAVEN

eribulin mesylate

Sponsor: EISAI INC

APPLICATION
NDA201532
TYPE
NDA
ORIGINAL APPROVAL
2010-11-15
LATEST ACTION
2022-09-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

HALAVEN · ReferencePrescription
ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-09-13Efficacy · Supplement 23 · priority — Letter ↗AP
2021-09-30Labeling · Supplement 21 · standard — Letter ↗AP
2021-02-19Labeling · Supplement 20 · standard — Letter ↗AP
2016-10-19Labeling · Supplement 16 · standard — Letter ↗AP
2016-07-21Manufacturing (CMC) · Supplement 17 · priorityAP
2016-01-28Efficacy · Supplement 15 · priority — Letter ↗AP
2015-11-18Manufacturing (CMC) · Supplement 14 · priorityAP
2015-10-27Labeling · Supplement 13 · standard — Letter ↗AP
2015-04-10Manufacturing (CMC) · Supplement 12 · priorityAP
2014-12-19Labeling · Supplement 10 · standard — Label ↗AP
2014-08-01Labeling · Supplement 9 · standard — Label ↗AP
2013-10-24Manufacturing (CMC) · Supplement 8 · priorityAP
2013-09-27Manufacturing (CMC) · Supplement 7 · priorityAP
2013-08-22Labeling · Supplement 6 · standard — Label ↗AP
2012-11-07Manufacturing (CMC) · Supplement 5 · priorityAP
2012-02-17Labeling · Supplement 4 · standard — Label ↗AP
2010-11-15Type 1 - New Molecular Entity · Original · priority — Label ↗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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