Treats urinary tract infections due to susceptible strains of Escherichia coli…. ANDA 216385, held by Novitium Pharma. Nitrofurantoin.
As of Nov 14, 2026, ANDA 216385 (Nitrofurantoin), held by Novitium Pharma, was first approved by FDA on Apr 14, 2023, with 1 approved supplement and 0 published complete response letters.
Nitrofurantoin 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 is not indicated for the treatment of pyelonephritis or perinephric abscesses. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin and other antibacterial drugs, nitrofurantoin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitrofurantoin25MG/5ML · suspension;oral | Nitrofurantoin | Rx |
| Sep 4, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 14, 2023 | Original application | Approved | None posted |
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
