NDA 65214, held by B Braun. Cefoxitin Sodium.
As of Nov 13, 2026, NDA 65214 (Cefoxitin And Dextrose In Duplex Container), held by B Braun, was first approved by FDA on Mar 10, 2006, with 6 approved supplements and 0 published complete response letters.
Cefoxitin for Injection and Dextrose Injection is a cephalosporin antibacterial indicated for the treatment of the following infections caused by susceptible isolates of the designated bacteria: Lower respiratory tract infections; Urinary tract infections; Intra-abdominal infections; Gynecological infections; Septicemia; Bone and joint infections; Skin and skin structure infections; Prophylaxis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 10, 2006 | Original application | Approved | None posted |
| Cefoxitin And Dextrose In Duplex ContainerEQ 1GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | RxReference drug |
| Cefoxitin And Dextrose In Duplex ContainerEQ 2GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | RxReference drug |
| Jul 29, 2019 | Supplement 16Labeling · Standard review | Approved | |
| Jun 5, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 12Manufacturing | Approved | None posted |
| Feb 22, 2010 | Supplement 8Labeling · Standard review | Approved | |
| Feb 4, 2010 | Supplement 2Labeling | Approved | |
| Jan 7, 2008 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 10, 2006 | Original application | Approved | None posted |
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
