Fosfomycin Oral Suspension

Brand(s)
Monurol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2011-04-18)
Oldest Current Product
1996-12-19
License(s)
NDA
RxNORM
ORAL SUSPENSION\FOSFOMYCIN
FDAOB
ORAL\FOR SUSPENSION\FOSFOMYCIN TROMETHAMINE
SPL Active
ORAL\POWDER\FOSFOMYCIN TROMETHAMINE
SPL Moiety
ORAL\POWDER\FOSFOMYCIN

product(s) by strength(s)

fosfomycin 33.3 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004564300MonurolNDAForest Laboratories, Inc1996-12-19FOSFOMYCIN TROMETHAMINEORALPOWDERNDA050717ad155d62-9b49-4a50-a2ae-d3aad8155936

application(s)

#idtitleapplicantapprovedapproved drug
1NDA050717MONUROLZAMBON SPA ITALY1996-12-19NDA050717_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA050717_001RXFOSFOMYCIN TROMETHAMINE (EQ 3GM BASE/PACKET)ORALFOR SUSPENSIONTrue1996-12-19MONUROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1ad155d62-9b49-4a50-a2ae-d3aad8155936 (view SPL)MONUROL[mon' ur ol](fosfomycin tromethamine)SACHETprescriptionHuman PrescriptionForest Laboratories, IncMANUFACTURE2011-04-186004564300

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