Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

MONUROL

FOSFOMYCIN TROMETHAMINE

Standard Dose
EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview MONUROL is listed in Drugs@FDA under application 050717 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FOSFOMYCIN TROMETHAMINE Form and strength FOR SOLUTION;ORAL - EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ZAMBON SPA Submission history Latest submission status date: 2018-11-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview MONUROL is listed in Drugs@FDA under application 050717 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FOSFOMYCIN TROMETHAMINE Form and strength FOR SOLUTION;ORAL - EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ZAMBON SPA Submission history Latest submission status date: 2018-11-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.