ANDA 65012, held by Fresenius Kabi USA. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 65012 (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 |
| CefoxitinEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | Discontinued |
| CefoxitinEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | Discontinued |
| Nov 26, 2007 | Supplement 7Labeling | Approved | None posted |
| Feb 13, 2004 | Supplement 3Labeling | Approved | None posted |
| Jul 23, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Dec 22, 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
