NDA 50309, held by Bristol. Ampicillin Sodium.
As of Nov 14, 2026, NDA 50309 (Polycillin-N), held by Bristol, was not approved, with 0 approved supplements and 0 published complete response letters.
| Polycillin-NEQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ampicillin Sodium | Discontinued |
| Polycillin-NEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ampicillin Sodium | Discontinued |
| Polycillin-NEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ampicillin Sodium | Discontinued |
| Polycillin-NEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ampicillin Sodium | Discontinued |
| Polycillin-NEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Ampicillin Sodium | Discontinued |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
