rufinamide Oral Suspension

Brand(s)
Banzel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2015-06-25)
Oldest Current Product
2011-03-03
License(s)
NDA
RxNORM
ORAL SUSPENSION\RUFINAMIDE
FDAOB
ORAL\SUSPENSION\RUFINAMIDE
SPL Active
ORAL\SUSPENSION\RUFINAMIDE
SPL Moiety
ORAL\SUSPENSION\RUFINAMIDE

product(s) by strength(s)

rufinamide 40 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560584BanzelNDAEisai Inc.2011-03-03RUFINAMIDEORALSUSPENSIONNDA2013670a3fa925-1abd-458a-bd57-4ae780a1ef2d

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201367BANZELEISAI INC2011-03-03p7750028, TREATMENT OF EPILEPSY
p6740669, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2015-11-14]
PEDIATRIC EXCLUSIVITY [2016-05-14]
NDA201367_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201367_001RXRUFINAMIDE (40MG/ML)ORALSUSPENSIONTrue2011-03-03BANZEL

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6740669 (view patent)2022-11-14NDA201367, NDA021911rufinamide Oral Tablet
2p7750028 (view patent)2018-10-19NDA201367, NDA021911rufinamide Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
10a3fa925-1abd-458a-bd57-4ae780a1ef2d (view SPL)These highlights do not include all the information needed to use BANZEL safely and effectively. See full prescribing information for BANZEL . BANZEL (rufinamide) film - coated t ablet, for o ral u se BANZEL (rufinamide) o ral s uspension Initial U.S. Approval: 2008prescriptionHuman PrescriptionEisai Inc.2015-06-2524628560584, 628560582, 628560583rufinamide Oral Tablet

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