APPLICATION
ANDA064036
TYPE
ANDA
ORIGINAL APPROVAL
1993-02-26
LATEST ACTION
2000-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFUROXIME SODIUMDiscontinued
CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-12-08Manufacturing (CMC) · Supplement 19AP
1998-08-26Manufacturing (CMC) · Supplement 18AP
1998-02-23Manufacturing (CMC) · Supplement 17AP
1997-08-20Manufacturing (CMC) · Supplement 14AP
1997-07-15Labeling · Supplement 15AP
1996-10-04Manufacturing (CMC) · Supplement 12AP
1996-10-04Manufacturing (CMC) · Supplement 13AP
1996-07-03Manufacturing (CMC) · Supplement 10AP
1996-05-06Labeling · Supplement 11AP
1996-03-06Labeling · Supplement 9AP
1995-10-27Manufacturing (CMC) · Supplement 8AP
1995-03-17Manufacturing (CMC) · Supplement 7AP
1994-12-13Labeling · Supplement 5AP
1994-08-18Manufacturing (CMC) · Supplement 6AP
1994-03-15Manufacturing (CMC) · Supplement 3AP
1994-03-15Manufacturing (CMC) · Supplement 4AP
1993-08-26Manufacturing (CMC) · Supplement 2AP
1993-05-20Labeling · Supplement 1AP
1993-02-26OriginalAP
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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