APPLICATION
NDA050588
TYPE
NDA
ORIGINAL APPROVAL
1985-12-27
LATEST ACTION
2017-03-09
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
CEFOTAN · ReferencePrescription
CEFOTETAN DISODIUM EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
CEFOTANDiscontinued
CEFOTETAN DISODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CEFOTAN · ReferencePrescription
CEFOTETAN DISODIUM EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2015-12-09Manufacturing (CMC) · Supplement 31 · standardAP
1999-08-05Labeling · Supplement 26 · standardAP
1995-10-20Labeling · Supplement 25 · standardAP
1995-09-12Labeling · Supplement 21 · standardAP
1994-09-15Manufacturing (CMC) · Supplement 23 · standardAP
1993-07-30Labeling · Supplement 22 · standardAP
1993-07-30Labeling · Supplement 20 · standardAP
1992-09-29Labeling · Supplement 19AP
1992-05-18Labeling · Supplement 18AP
1991-11-25Labeling · Supplement 4AP
1991-11-25Efficacy · Supplement 2AP
1991-11-25Labeling · Supplement 16AP
1991-11-25Labeling · Supplement 14AP
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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