APPLICATION
ANDA062640
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-20
LATEST ACTION
2021-07-16
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
CEFTAZIDIMEPrescription
CEFTAZIDIME 2GM/VIAL · INJECTABLE · INJECTION
CEFTAZIDIMEDiscontinued
CEFTAZIDIME 500MG/VIAL · INJECTABLE · INJECTION
CEFTAZIDIMEPrescription
CEFTAZIDIME 6GM/VIAL · INJECTABLE · INJECTION
CEFTAZIDIMEPrescription
CEFTAZIDIME 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2021-07-16Labeling · Supplement 44 · standardAP
2021-07-16Labeling · Supplement 45 · standardAP
2020-02-13Labeling · Supplement 42 · standardAP
2020-02-13Labeling · Supplement 40 · standardAP
2013-02-11Labeling · Supplement 34AP
2012-03-16Labeling · Supplement 33AP
2009-04-07Labeling · Supplement 30AP
2006-09-08Labeling · Supplement 24AP
1996-08-15Manufacturing (CMC) · Supplement 20AP
1996-07-15Labeling · Supplement 21AP
1996-02-26Labeling · Supplement 19AP
1993-10-18Manufacturing (CMC) · Supplement 18AP
1992-02-14Labeling · Supplement 13AP
1992-02-14Labeling · Supplement 14AP
1992-02-14Labeling · Supplement 10AP
1992-02-03Labeling · Supplement 15AP
1988-08-26Manufacturing (CMC) · Supplement 9AP
1988-08-04Manufacturing (CMC) · Supplement 8AP
1985-11-20OriginalAP
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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