NDA 50554, held by Bristol. Ceforanide.
As of Nov 13, 2026, NDA 50554 (Precef), held by Bristol, was first approved by FDA on May 24, 1984, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 1984 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Precef500MG/VIAL · injectable;injection | Ceforanide | Discontinued |
| Precef1GM/VIAL · injectable;injection | Ceforanide | Discontinued |
| Precef2GM/VIAL · injectable;injection | Ceforanide | Discontinued |
| Precef10GM/VIAL · injectable;injection | Ceforanide | Discontinued |
| Precef20GM/VIAL · injectable;injection | Ceforanide | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters