APPLICATION
ANDA062662
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-06
LATEST ACTION
2021-10-19
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
TAZICEFDiscontinued
CEFTAZIDIME 500MG/VIAL · INJECTABLE · INJECTION
TAZICEFPrescription
CEFTAZIDIME 6GM/VIAL · INJECTABLE · INJECTION
TAZICEFPrescription
CEFTAZIDIME 1GM/VIAL · INJECTABLE · INJECTION
TAZICEFPrescription
CEFTAZIDIME 2GM/VIAL · INJECTABLE · INJECTION
Approval history
2021-10-19Labeling · Supplement 32 · standardAP
2021-10-19Labeling · Supplement 37 · standardAP
2016-03-14Labeling · Supplement 27 · standardAP
2016-03-14Labeling · Supplement 23AP
2005-03-08Labeling · Supplement 20AP
1999-07-13Labeling · Supplement 17AP
1996-01-17Manufacturing (CMC) · Supplement 16AP
1994-12-09Manufacturing (CMC) · Supplement 15AP
1994-04-04Labeling · Supplement 14AP
1992-12-17Labeling · Supplement 12AP
1992-11-09Manufacturing (CMC) · Supplement 13AP
1990-07-18Manufacturing (CMC) · Supplement 10AP
1989-07-07Manufacturing (CMC) · Supplement 8AP
1988-07-25Manufacturing (CMC) · Supplement 7AP
1986-03-06OriginalAP
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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