Treats serious infections caused by susceptible strains of the designated microorganisms…. ANDA 200938, held by Samson Medcl. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 200938 (Cefoxitin In Plastic Container), held by Samson Medcl, was first approved by FDA on Nov 16, 2015, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin and other antibacterial drugs, Cefoxitin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cefoxitin In Plastic ContainerEQ 100GM BASE · powder;intravenous | Cefoxitin Sodium | 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
