ioxilan Injectable Solution

Brand(s)
Oxilan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Guerbet Llc (2015-09-14)
Oldest Current Product
2002-03-18
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\IOXILAN
FDAOB
INJECTION\INJECTION\IOXILAN\rdfq
SPL Active
INTRAVASCULAR\INJECTION, SOLUTION\IOXILAN
SPL Moiety
INTRAVASCULAR\INJECTION, SOLUTION\IOXILAN

product(s) by strength(s)

ioxilan 623 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1676841000OxilanNDAGuerbet Llc2002-03-182016-04-30IOXILANINTRAVASCULARINJECTION, SOLUTIONNDA020316ae692163-dfbf-4271-87ad-4ed888caa513

ioxilan 727 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1676841001OxilanNDAGuerbet Llc2002-03-182016-04-30IOXILANINTRAVASCULARINJECTION, SOLUTIONNDA020316ae692163-dfbf-4271-87ad-4ed888caa513

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020316OXILAN-300GUERBET LLC1995-12-21NDA020316_001, NDA020316_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020316_001RXIOXILAN (62%)INJECTIONFalse1995-12-21OXILAN-300
2NDA020316_002RXIOXILAN (73%)INJECTIONFalse1995-12-21OXILAN-300

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ae692163-dfbf-4271-87ad-4ed888caa513 (view SPL)OXILAN (Ioxilan Injection) 300 mgI/mLOXILAN (Ioxilan Injection) 350 mgI/mLOXILAN (Ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package Nonionic Contrast AgentsprescriptionHuman PrescriptionGuerbet Llcanalysis, api manufacture, manufacture, pack2015-09-1410676841000, 676841001

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