APPLICATION
ANDA064032
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2022-03-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TAZICEFPrescription
CEFTAZIDIME 1GM/VIAL · INJECTABLE · INJECTION
TAZICEFPrescription
CEFTAZIDIME 2GM/VIAL · INJECTABLE · INJECTION
Approval history
2022-03-03Labeling · Supplement 16 · standardAP
2022-03-03Labeling · Supplement 14 · standardAP
2022-03-03Labeling · Supplement 20 · standardAP
2022-03-03Labeling · Supplement 25 · standardAP
2012-03-12Labeling · Supplement 10AP
2005-11-28Labeling · Supplement 9AP
1998-05-28Manufacturing (CMC) · Supplement 3AP
1996-05-24Manufacturing (CMC) · Supplement 2AP
1995-07-05Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
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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