Treats urinary tract infections. ANDA 211935, held by Alembic. Nitrofurantoin, Macrocrystalline.
As of Nov 15, 2026, ANDA 211935 (Nitrofurantoin), held by Alembic, was first approved by FDA on Jun 25, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nitrofurantoin capsules, USP (macrocrystals) 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2021 | Original application | Approved | None posted |
| Nitrofurantoin25MG · capsule;oral | Nitrofurantoin, Macrocrystalline | Rx |
| Nitrofurantoin50MG · capsule;oral | Nitrofurantoin, Macrocrystalline | Rx |
| Nitrofurantoin100MG · capsule;oral | Nitrofurantoin, Macrocrystalline | 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
