Floxuridine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2012-08-17)
Oldest Current Product
2001-03-15
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\FLOXURIDINE
FDAOB
INJECTION\INJECTION\FLOXURIDINE\rdfq
SPL Active
INTRA-ARTERIAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLOXURIDINE
SPL Moiety
INTRA-ARTERIAL\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\FLOXURIDINE

product(s) by strength(s)

floxuridine 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230145ANDAApp Pharmaceuticals, Llc2001-03-15FLOXURIDINEINTRA-ARTERIALINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA075837c8edabc1-67cd-421b-a147-7c1f19f05b8e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075387FLOXURIDINEEUROHEALTH INTERNATIONAL SARL2000-04-16ANDA075387_001
2ANDA075837FLOXURIDINEFRESENIUS KABI USA LLC2001-02-22ANDA075837_001
3NDA016929FUDRTrueHOSPIRA INCNDA016929_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075387_001RXFLOXURIDINE (500MG/VIAL)INJECTIONTrueAP2000-04-16FLOXURIDINE
2ANDA075837_001RXFLOXURIDINE (500MG/VIAL)INJECTIONFalseAP2001-02-22FLOXURIDINE
3NDA016929_001discontinuedFLOXURIDINE (500MG/VIAL)INJECTIONFalseFUDR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1c8edabc1-67cd-421b-a147-7c1f19f05b8e (view SPL)Floxuridine for Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-171633230145

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