eribulin Injectable Solution

Brand(s)
Halaven
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2015-10-29)
Oldest Current Product
2010-11-15
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\ERIBULIN
FDAOB
INTRAVENOUS\SOLUTION\ERIBULIN MESYLATE
SPL Active
INTRAVENOUS\INJECTION\ERIBULIN MESYLATE
SPL Moiety
INTRAVENOUS\INJECTION\ERIBULIN

product(s) by strength(s)

eribulin mesylate 0.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560389HalavenNDAEisai Inc.2010-11-15ERIBULIN MESYLATEINTRAVENOUSINJECTIONNDA20153231ce4750-ded5-4a0b-95e9-f229fa6bc822

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201532HALAVENEISAI INC2010-11-15p6214865
p6469182, TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
p7470720, SUBSTANCE
p8097648, TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
NEW CHEMICAL ENTITY [2015-11-15]NDA201532_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201532_001RXERIBULIN MESYLATE (1MG/2ML)INTRAVENOUSSOLUTIONTrue2010-11-15HALAVEN

patent(s)

#idexpiration dateapplication(s)
1p6214865 (view patent)2023-07-20NDA201532
2p6469182 (view patent)2019-06-16NDA201532
3p7470720 (view patent)2019-06-16NDA201532
4p8097648 (view patent)2021-01-22NDA201532

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
131ce4750-ded5-4a0b-95e9-f229fa6bc822 (view SPL)These highlights do not include all the information needed to use HALAVEN safely and effectively. See full prescribing information for HALAVEN. HALAVEN (eribulin mesylate) Injection For intravenous administration Initial U.S. Approval: 2010prescriptionHuman PrescriptionEisai Inc.2015-10-2939628560389

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII