NDA 50517, held by Pharmobedient. Cefoxitin Sodium.
As of Nov 13, 2026, NDA 50517 (Mefoxin), held by Pharmobedient, was first approved by FDA on Oct 18, 1978, with 21 approved supplements and 0 published complete response letters.
| Jul 30, 1996 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| Feb 28, 1995 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| Oct 18, 1978 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| MefoxinEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| MefoxinEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| MefoxinEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefoxitin Sodium | DiscontinuedReference drug |
| Mar 9, 2017 | Supplement 53Labeling · Standard review | Approved | |
| May 10, 2013 | Supplement 51Labeling · Standard review | Approved | |
| Feb 4, 2011 | Supplement 50Labeling | Approved | |
| Sep 17, 2007 | Supplement 47Labeling · Standard review | Approved | |
| Jun 28, 2004 | Supplement 45Labeling · Standard review | Approved | |
| Jun 28, 2004 | Supplement 42Labeling · Standard review | Approved | |
| Jun 2, 2004 | Supplement 46Labeling · Standard review | Approved | |
| Jun 6, 2002 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| May 7, 2002 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Oct 19, 2001 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Feb 14, 2000 | Supplement 38Labeling · Standard review | Approved | |
| Oct 12, 1999 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1997 | Supplement 39Labeling · Standard review | Approved | |
| Feb 27, 1997 | Supplement 31Labeling | Approved | |
| Oct 11, 1996 | Supplement 37Labeling · Standard review | Approved | None posted |
| Jul 30, 1996 | Supplement 28Efficacy (new indication or use) | Approved | None posted |
| May 20, 1996 | Supplement 35Labeling · Standard review | Approved | None posted |
| May 20, 1996 | Supplement 32Labeling | Approved | None posted |
| Feb 28, 1995 | Supplement 29Efficacy (new indication or use) | Approved | None posted |
| Nov 30, 1994 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Oct 27, 1994 | Supplement 33Labeling · Standard review | Approved | None posted |
| Oct 18, 1978 | Original applicationNew molecular entity · Priority review | 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
