Treats urinary tract infections due to susceptible strains of Escherichia coli…. ANDA 208909, held by Somerset Theraps LLC. Nitrofurantoin.
As of Nov 14, 2026, ANDA 208909 (Nitrofurantoin), held by Somerset Theraps LLC, was first approved by FDA on Jan 14, 2025, with 0 approved supplements and 0 published complete response letters.
Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli, Enterococcus species, Staphylococcus aureus, Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitrofurantoin25MG/5ML · suspension;oral | Nitrofurantoin | 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
