clobazam Oral Suspension

Brand(s)
Onfi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lundbeck Inc. (2014-12-22)
Oldest Current Product
2012-12-14
License(s)
NDA
RxNORM
ORAL SUSPENSION\CLOBAZAM
FDAOB
ORAL\SUSPENSION\CLOBAZAM
SPL Active
ORAL\SUSPENSION\CLOBAZAM
SPL Moiety
ORAL\SUSPENSION\CLOBAZAM

product(s) by strength(s)

clobazam 2.5 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860313OnfiNDALundbeck Inc.2012-12-14CLOBAZAMORALSUSPENSIONNDA203993de03bd69-2dca-459c-93b4-541fd3e9571c

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA203993ONFILUNDBECK LLC2012-12-14NEW CHEMICAL ENTITY [2016-10-21]
ORPHAN DRUG EXCLUSIVITY [2018-10-21]
NDA203993_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203993_001RXCLOBAZAM (2.5MG/ML)ORALSUSPENSIONTrue2012-12-14ONFI

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1de03bd69-2dca-459c-93b4-541fd3e9571c (view SPL)These highlights do not include all the information needed to use ONFI safely and effectively. See full prescribing information for ONFI. ONFI (clobazam) tablets, for oral use, CIV ONFI (clobazam) oral suspension, CIV Initial U.S. Approval: 2011prescriptionHuman PrescriptionLundbeck Inc.API MANUFACTURE, MANUFACTURE2014-12-2213673860313, 673860310, 673860311, 673860312, 673860314, 673860315clobazam Oral Tablet

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