vismodegib Oral Capsule

Brand(s)
Erivedge
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-05-30)
Oldest Current Product
2012-01-30
License(s)
NDA
RxNORM
ORAL CAPSULE\VISMODEGIB
FDAOB
ORAL\CAPSULE\VISMODEGIB
SPL Active
ORAL\CAPSULE\VISMODEGIB
SPL Moiety
ORAL\CAPSULE\VISMODEGIB

product(s) by strength(s)

vismodegib 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420140ErivedgeNDAGenentech, Inc.2012-01-30VISMODEGIBORALCAPSULENDA203388eb368bb6-80e3-4df9-8a85-91df0a2ada6a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203388ERIVEDGEGENENTECH INC2012-01-30p7888364, SUBSTANCENEW CHEMICAL ENTITY [2017-01-30]NDA203388_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203388_001RXVISMODEGIB (150MG)ORALCAPSULETrue2012-01-30ERIVEDGE

patent(s)

#idexpiration dateapplication(s)
1p7888364 (view patent)2028-11-11NDA203388

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1eb368bb6-80e3-4df9-8a85-91df0a2ada6a (view SPL)These highlights do not include all the information needed to use ERIVEDGE safely and effectively. See full prescribing information for ERIVEDGE. ERIVEDGE (vismodegib) capsule for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, LABEL, PACK2015-05-304502420140

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