ANDA 65011, held by Fresenius Kabi USA. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65011 (Cefoxitin), held by Fresenius Kabi USA, was first approved by FDA on Jul 3, 2000, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CefoxitinEQ 10GM BASE/VIAL ยท injectable;injection | Cefoxitin Sodium | Discontinued |
| Nov 26, 2007 | Supplement 6Labeling | Approved | None posted |
| Feb 13, 2004 | Supplement 3Labeling | Approved | None posted |
| Jul 23, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Oct 18, 2000 | Supplement 1Labeling | Approved | None posted |
| Jul 3, 2000 | Original application | 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
