Treats urinary tract infections. ANDA 201693, held by Novel Labs Inc. Nitrofurantoin.
As of Nov 14, 2026, ANDA 201693 (Nitrofurantoin), held by Novel Labs Inc, was first approved by FDA on Sep 8, 2014, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Nitrofurantoin Oral Suspension, USP is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin oral suspension, USP are predisposed to persistence or reappearance of bacteriuria.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nitrofurantoin25MG/5ML · suspension;oral | Nitrofurantoin | Rx |
| Jun 24, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 8, 2014 | 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
