APPLICATION
ANDA062659
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-13
LATEST ACTION
2015-11-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CLAFORANDiscontinued
CEFOTAXIME SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CLAFORANDiscontinued
CEFOTAXIME SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2015-11-02Labeling · Supplement 41AP
2010-04-28Labeling · Supplement 42AP
2008-10-31Labeling · Supplement 40AP
2005-11-01Labeling · Supplement 35AP
2005-11-01Labeling · Supplement 34AP
2002-06-18Manufacturing (CMC) · Supplement 31AP
2001-10-01Manufacturing (CMC) · Supplement 30AP
2001-08-13Manufacturing (CMC) · Supplement 29AP
2001-03-19Manufacturing (CMC) · Supplement 28AP
2001-02-07Manufacturing (CMC) · Supplement 27AP
2000-05-08Manufacturing (CMC) · Supplement 26AP
1998-08-10Labeling · Supplement 20AP
1998-07-09Manufacturing (CMC) · Supplement 25AP
1998-03-17Manufacturing (CMC) · Supplement 23AP
1998-03-17Manufacturing (CMC) · Supplement 24AP
1996-07-31Labeling · Supplement 15AP
1996-07-31Labeling · Supplement 11AP
1996-07-31Labeling · Supplement 9AP
1996-07-31Labeling · Supplement 12AP
1995-12-20Manufacturing (CMC) · Supplement 17AP
1995-12-20Manufacturing (CMC) · Supplement 16AP
1995-08-30Manufacturing (CMC) · Supplement 4AP
1994-07-14Manufacturing (CMC) · Supplement 14AP
1994-01-14Manufacturing (CMC) · Supplement 13AP
1992-12-17Manufacturing (CMC) · Supplement 6AP
1992-11-09Manufacturing (CMC) · Supplement 8AP
1992-11-09Manufacturing (CMC) · Supplement 7AP
1992-07-17Manufacturing (CMC) · Supplement 5AP
1989-08-07Manufacturing (CMC) · Supplement 1AP
1987-01-13OriginalAP
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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