ANDA 80078, held by Ivax Sub Teva Pharms. Nitrofurantoin.
As of Nov 14, 2026, ANDA 80078 (Nitrofurantoin), held by Ivax Sub Teva Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Nitrofurantoin100MG · tablet;oral | Nitrofurantoin | Discontinued |
| Nitrofurantoin50MG · tablet;oral | Nitrofurantoin | Discontinued |
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
