Treats urinary tract infections due to susceptible strains of Escherichia coli…. ANDA 218346, held by Biocon Pharma. Nitrofurantoin.
As of Nov 14, 2026, ANDA 218346 (Nitrofurantoin), held by Biocon Pharma, was first approved by FDA on Oct 28, 2024, 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 |
|---|---|---|---|
| Oct 28, 2024 | 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
