APPLICATION
ANDA062757
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-08
LATEST ACTION
2008-01-31
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MEFOXINDiscontinued
CEFOXITIN SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
MEFOXINDiscontinued
CEFOXITIN SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2008-01-31Labeling · Supplement 25AP
2004-12-02Labeling · Supplement 24AP
2004-02-06Labeling · Supplement 22AP
2004-02-06Labeling · Supplement 23AP
2002-09-30Manufacturing (CMC) · Supplement 21AP
2002-08-22Labeling · Supplement 15AP
2002-06-04Manufacturing (CMC) · Supplement 20AP
2002-06-04Manufacturing (CMC) · Supplement 19AP
2001-12-06Manufacturing (CMC) · Supplement 18AP
1999-12-17Manufacturing (CMC) · Supplement 17AP
1999-02-18Labeling · Supplement 12AP
1997-07-11Labeling · Supplement 16AP
1997-07-11Labeling · Supplement 8AP
1996-07-16Labeling · Supplement 11AP
1996-05-08Manufacturing (CMC) · Supplement 14AP
1996-02-26Labeling · Supplement 9AP
1996-02-26Labeling · Supplement 13AP
1995-03-20Manufacturing (CMC) · Supplement 10AP
1992-03-10Manufacturing (CMC) · Supplement 5AP
1992-02-10Labeling · Supplement 2AP
1992-02-10Manufacturing (CMC) · Supplement 3AP
1987-01-08OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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