NDA 50581, held by Merck. Cefoxitin Sodium.
As of Nov 14, 2026, NDA 50581 (Mefoxin In Sodium Chloride 0.9% In Plastic Container, Mefoxin In Dextrose 5% In Plastic Container), held by Merck, was not approved, with 1 approved supplement and 0 published complete response letters.
| Mefoxin In Sodium Chloride 0.9% In Plastic ContainerEQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| Mefoxin In Sodium Chloride 0.9% In Plastic ContainerEQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| Mefoxin In Dextrose 5% In Plastic ContainerEQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| Mefoxin In Dextrose 5% In Plastic ContainerEQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 1997 | Supplement 20 | Approved |
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
