Treats uncomplicated urinary tract infections (acute cystitis). ANDA 212548, held by Xiromed. Fosfomycin Tromethamine.
As of Nov 15, 2026, ANDA 212548 (Fosfomycin Tromethamine), held by Xiromed, was first approved by FDA on Oct 6, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosfomycin TromethamineEQ 3GM BASE/PACKET · for solution;oral | Fosfomycin Tromethamine | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
