APPLICATION
NDA050560
TYPE
NDA
ORIGINAL APPROVAL
1983-09-15
LATEST ACTION
2005-01-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEFIZOXDiscontinued
CEFTIZOXIME SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
CEFIZOXDiscontinued
CEFTIZOXIME SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFIZOXDiscontinued
CEFTIZOXIME SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
CEFIZOXDiscontinued
CEFTIZOXIME SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2000-08-07Manufacturing (CMC) · Supplement 52 · standardAP
1996-02-13Labeling · Supplement 50 · standardAP
1995-12-14Labeling · Supplement 49 · standardAP
1995-07-10Manufacturing (CMC) · Supplement 48 · standardAP
1993-03-19Labeling · Supplement 46 · standardAP
1992-06-23Efficacy · Supplement 36 · standardAP
1992-01-22Labeling · Supplement 43 · standardAP
1989-05-05Manufacturing (CMC) · Supplement 38 · standardAP
1987-04-29Manufacturing (CMC) · Supplement 33 · standardAP
1983-09-15Type 1 - New Molecular Entity · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.