APPLICATION
NDA050646
TYPE
NDA
ORIGINAL APPROVAL
1990-09-27
LATEST ACTION
2002-03-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CEPTAZDiscontinued
CEFTAZIDIME 2GM/VIAL · INJECTABLE · INJECTION
CEPTAZDiscontinued
CEFTAZIDIME 500MG/VIAL · INJECTABLE · INJECTION
CEPTAZDiscontinued
CEFTAZIDIME 10GM/VIAL · INJECTABLE · INJECTION
CEPTAZDiscontinued
CEFTAZIDIME 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2002-02-22Manufacturing (CMC) · Supplement 17 · standardAP
2000-02-23Manufacturing (CMC) · Supplement 15 · standardAP
1998-01-26Labeling · Supplement 8 · standardAP
1997-11-25Manufacturing (CMC) · Supplement 13 · standardAP
1997-04-03Manufacturing (CMC) · Supplement 12 · standardAP
1996-12-24Labeling · Supplement 11 · standardAP
1996-09-11Labeling · Supplement 6 · standardAP
1996-08-20Labeling · Supplement 7 · standardAP
1996-06-20Labeling · Supplement 10 · standardAP
1996-06-20Labeling · Supplement 9 · standardAP
1994-10-20Labeling · Supplement 5 · standardAP
1994-09-07Labeling · Supplement 4 · standardAP
1992-09-10Manufacturing (CMC) · Supplement 2 · standardAP
1992-09-09Manufacturing (CMC) · Supplement 1 · standardAP
1991-08-09Manufacturing (CMC) · Supplement 3 · standardAP
1990-09-27Type 2 - New Active Ingredient · 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.
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