Budesonide Rectal Foam

Brand(s)
Uceris
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2014-10-20)
Oldest Current Product
2014-12-01
License(s)
NDA
RxNORM
RECTAL FOAM\BUDESONIDE
FDAOB
RECTAL\AEROSOL, FOAM\BUDESONIDE
SPL Active
RECTAL\AEROSOL, FOAM\BUDESONIDE
SPL Moiety
RECTAL\AEROSOL, FOAM\BUDESONIDE

product(s) by strength(s)

14 actuat budesonide 2 mg/actuat rectal foam

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490651UcerisNDASalix Pharmaceuticals, Inc.2014-12-01BUDESONIDERECTALAEROSOL, FOAMNDA205613230e4596-2a9b-4d55-b0a0-0cabbcff5289

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205613UCERISVALEANT PHARMACEUTICALS INTERNATIONAL2014-10-07p5914122, SUBSTANCENEW PRODUCT [2017-10-07]NDA205613_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205613_001RXBUDESONIDE (2MG/ACTUATION)RECTALAEROSOL, FOAMTrue2014-10-07UCERIS

patent(s)

#idexpiration dateapplication(s)
1p5914122 (view patent)2015-12-19NDA205613

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1230e4596-2a9b-4d55-b0a0-0cabbcff5289 (view SPL)These highlights do not include all the information needed to use UCERIS rectal foam safely and effectively. See full prescribing information for UCERIS rectal foam. UCERIS (budesonide) rectal foam Initial U.S. Approval: 1997prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.API MANUFACTURE2014-10-2010656490651

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