clobazam Oral Tablet

Brand(s)
Onfi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lundbeck Inc. (2014-12-22)
Oldest Current Product
2011-10-21
License(s)
NDA
RxNORM
ORAL TABLET\CLOBAZAM
FDAOB
ORAL\TABLET\CLOBAZAM
SPL Active
ORAL\TABLET\CLOBAZAM
SPL Moiety
ORAL\TABLET\CLOBAZAM

product(s) by strength(s)

clobazam 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860314OnfiNDALundbeck Inc.2013-12-10CLOBAZAMORALTABLETNDA202067de03bd69-2dca-459c-93b4-541fd3e9571c

clobazam 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1673860315OnfiNDALundbeck Inc.2013-12-10CLOBAZAMORALTABLETNDA202067de03bd69-2dca-459c-93b4-541fd3e9571c

clobazam 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1673860310OnfiNDALundbeck Inc.2011-10-212016-02-28CLOBAZAMORALTABLETNDA202067de03bd69-2dca-459c-93b4-541fd3e9571c

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA202067ONFILUNDBECK LLC2011-10-21NEW CHEMICAL ENTITY [2016-10-21]
ORPHAN DRUG EXCLUSIVITY [2018-10-21]
NDA202067_001, NDA202067_002, NDA202067_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202067_001discontinuedCLOBAZAM (5MG)ORALTABLETFalse2011-10-21ONFI
2NDA202067_002RXCLOBAZAM (10MG)ORALTABLETFalse2011-10-21ONFI
3NDA202067_003RXCLOBAZAM (20MG)ORALTABLETTrue2011-10-21ONFI

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, MANUFACTURE2014-12-2213673860310, 673860314, 673860315, 673860311, 673860312, 673860313clobazam Oral Suspension

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