ANDA 63182, held by Pharmobedient. Cefoxitin Sodium.
As of Nov 15, 2026, ANDA 63182 (Mefoxin In Plastic Container), held by Pharmobedient, was first approved by FDA on Jan 25, 1993, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 1993 | Original application | Approved | None posted |
| Mefoxin In Plastic ContainerEQ 20MG BASE/ML · injectable;injection | Cefoxitin Sodium | Discontinued |
| Mefoxin In Plastic ContainerEQ 40MG BASE/ML · injectable;injection | Cefoxitin Sodium | Discontinued |
| Mar 7, 2017 | Supplement 18Labeling | Approved | None posted |
| Feb 12, 2009 | Supplement 15Labeling | Approved | None posted |
| Jan 31, 2008 | Supplement 14Labeling | Approved | None posted |
| Dec 6, 2004 | Supplement 11Labeling | Approved | None posted |
| Nov 5, 2004 | Supplement 13Labeling | Approved | None posted |
| Feb 6, 2004 | Supplement 12Labeling | Approved | None posted |
| Aug 22, 2002 | Supplement 6Labeling | Approved | None posted |
| Jun 4, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Jun 4, 2002 | Supplement 9Manufacturing | Approved | None posted |
| Dec 6, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Dec 17, 1999 | Supplement 7Manufacturing | Approved | None posted |
| Apr 4, 1998 | Supplement 3Labeling | Approved | None posted |
| Jul 11, 1997 | Supplement 1Labeling | Approved | None posted |
| Jul 29, 1996 | Supplement 4Labeling | Approved | None posted |
| Feb 26, 1996 | Supplement 2Labeling | Approved | None posted |
| May 31, 1995 | Supplement 5Labeling | Approved | None posted |
| Jan 25, 1993 | 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
