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FDA NDA · NDA050589

CEFIZOX IN PLASTIC CONTAINER

Sponsor: ASTELLAS

APPLICATION
NDA050589
TYPE
NDA
ORIGINAL APPROVAL
1984-10-03
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFIZOX IN PLASTIC CONTAINERDiscontinued
CEFTIZOXIME SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CEFTIZOXIME SODIUM EQ 40MG BASE/ML · INJECTABLE · INJECTION
CEFIZOX IN PLASTIC CONTAINERDiscontinued
CEFTIZOXIME SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CEFTIZOXIME SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION

Approval history

2009-03-13Labeling · Supplement 8AP
2009-03-13Labeling · Supplement 5AP
2005-01-14Labeling · Supplement 13 · standard — Letter ↗AP
1996-02-26Manufacturing (CMC) · Supplement 12 · standardAP
1995-04-13Manufacturing (CMC) · Supplement 9 · standardAP
1993-05-24Labeling · Supplement 11 · standardAP
1992-09-25Labeling · Supplement 10AP
1992-02-06Labeling · Supplement 6AP
1992-02-06Manufacturing (CMC) · Supplement 4 · standardAP
1992-02-06Manufacturing (CMC) · Supplement 7 · standardAP
1986-02-12Manufacturing (CMC) · Supplement 3 · standardAP
1985-07-15Labeling · Supplement 2AP
1985-04-16Manufacturing (CMC) · Supplement 1 · standardAP
1984-10-03Type 3 - New Dosage Form · Original · standardAP
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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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