APPLICATION
ANDA064200
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-24
LATEST ACTION
2008-04-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFOTAXIMEDiscontinued
CEFOTAXIME SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
CEFOTAXIMEDiscontinued
CEFOTAXIME SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFOTAXIMEDiscontinued
CEFOTAXIME SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2008-04-30Labeling · Supplement 11AP
2005-09-01Labeling · Supplement 10AP
2004-03-17Labeling · Supplement 7AP
2004-03-17Labeling · Supplement 8AP
2002-08-13Manufacturing (CMC) · Supplement 6AP
2002-03-28Manufacturing (CMC) · Supplement 4AP
2002-01-04Manufacturing (CMC) · Supplement 3AP
2001-06-28Manufacturing (CMC) · Supplement 1AP
2001-06-28Manufacturing (CMC) · Supplement 2AP
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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