APPLICATION
ANDA062591
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-10
LATEST ACTION
2002-11-12
ROUTE
INJECTION, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
KEFUROXDiscontinued
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
KEFUROXDiscontinued
CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL · INJECTABLE · INJECTION
KEFUROXDiscontinued
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
Approval history
2002-11-12Labeling · Supplement 38AP
2002-11-12Labeling · Supplement 36AP
2002-11-12Labeling · Supplement 37AP
2002-11-12Labeling · Supplement 35AP
2002-09-04Manufacturing (CMC) · Supplement 34AP
2001-09-05Manufacturing (CMC) · Supplement 33AP
2001-01-22Labeling · Supplement 32AP
2001-01-22Manufacturing (CMC) · Supplement 30AP
2001-01-22Manufacturing (CMC) · Supplement 29AP
2001-01-22Manufacturing (CMC) · Supplement 31AP
1999-01-20Labeling · Supplement 26AP
1999-01-20Manufacturing (CMC) · Supplement 25AP
1997-01-23Manufacturing (CMC) · Supplement 18AP
1997-01-23Labeling · Supplement 20AP
1997-01-13Manufacturing (CMC) · Supplement 19AP
1996-08-15Manufacturing (CMC) · Supplement 24AP
1996-08-15Manufacturing (CMC) · Supplement 22AP
1996-08-15Labeling · Supplement 23AP
1994-02-03Labeling · Supplement 11AP
1992-06-12Labeling · Supplement 16AP
1992-06-12Manufacturing (CMC) · Supplement 10AP
1991-12-10Labeling · Supplement 15AP
1986-01-10OriginalAP
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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