ANDA 62757, held by Pharmobedient. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 62757 (Mefoxin), held by Pharmobedient, was first approved by FDA on Jan 8, 1987, with 21 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 1987 | Original application | Approved | None posted |
| MefoxinEQ 1GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Discontinued |
| MefoxinEQ 2GM BASE/VIAL · injectable;injection | Cefoxitin Sodium | Discontinued |
| Jan 31, 2008 | Supplement 25Labeling | Approved | None posted |
| Dec 2, 2004 | Supplement 24Labeling | Approved | None posted |
| Feb 6, 2004 | Supplement 23Labeling | Approved | None posted |
| Feb 6, 2004 | Supplement 22Labeling | Approved | None posted |
| Sep 30, 2002 | Supplement 21Manufacturing | Approved | None posted |
| Aug 22, 2002 | Supplement 15Labeling | Approved | None posted |
| Jun 4, 2002 | Supplement 20Manufacturing | Approved | None posted |
| Jun 4, 2002 | Supplement 19Manufacturing | Approved | None posted |
| Dec 6, 2001 | Supplement 18Manufacturing | Approved | None posted |
| Dec 17, 1999 | Supplement 17Manufacturing | Approved | None posted |
| Feb 18, 1999 | Supplement 12Labeling | Approved | None posted |
| Jul 11, 1997 | Supplement 16Labeling | Approved | None posted |
| Jul 11, 1997 | Supplement 8Labeling | Approved | None posted |
| Jul 16, 1996 | Supplement 11Labeling | Approved | None posted |
| May 8, 1996 | Supplement 14Manufacturing | Approved | None posted |
| Feb 26, 1996 | Supplement 13Labeling | Approved | None posted |
| Feb 26, 1996 | Supplement 9Labeling | Approved | None posted |
| Mar 20, 1995 | Supplement 10Manufacturing | Approved | None posted |
| Mar 10, 1992 | Supplement 5Manufacturing | Approved | None posted |
| Feb 10, 1992 | Supplement 3Manufacturing | Approved | None posted |
| Feb 10, 1992 | Supplement 2Labeling | Approved | None posted |
| Jan 8, 1987 | 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
