belinostat Injectable Solution

Brand(s)
Beleodaq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Spectrum Pharmaceuticals, Inc. (2014-07-16)
Oldest Current Product
2014-07-21
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\BELINOSTAT
FDAOB
IV (INFUSION)\POWDER\BELINOSTAT\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BELINOSTAT
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\BELINOSTAT

product(s) by strength(s)

belinostat 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681520108BeleodaqNDASpectrum Pharmaceuticals, Inc.2014-07-21BELINOSTATINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA20625684b2e16e-f0d1-4757-8da8-79dfa83aab79

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206256BELEODAQSPECTRUM PHARMACEUTICALS INC2014-07-03p8835501, SUBSTANCE
p6888027, TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL)., SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2021-07-03]
NEW CHEMICAL ENTITY [2019-07-03]
NDA206256_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206256_001RXBELINOSTAT (500MG/VIAL)POWDERTrue2014-07-03BELEODAQ

patent(s)

#idexpiration dateapplication(s)
1p6888027 (view patent)2021-09-27NDA206256
2p8835501 (view patent)2027-10-27NDA206256

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
184b2e16e-f0d1-4757-8da8-79dfa83aab79 (view SPL)These highlights do not include all the information needed to use BELEODAQ safely and effectively. See full prescribing information for BELEODAQ. BELEODAQ (belinostat) for injection, for intravenous administrationInitial U.S. Approval: 2014prescriptionHuman PrescriptionSpectrum Pharmaceuticals, Inc.2014-07-162681520108

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