APPLICATION
NDA050504
TYPE
NDA
ORIGINAL APPROVAL
1978-09-27
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 10GM BASE/VIAL · INJECTABLE · INJECTION
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 15AP
2009-03-13Labeling · Supplement 11AP
2009-03-13Labeling · Supplement 18AP
2009-03-13Labeling · Supplement 24AP
2009-03-13Labeling · Supplement 20AP
2009-03-13Labeling · Supplement 63 · standardAP
2002-05-22Manufacturing (CMC) · Supplement 64 · priorityAP
1999-01-05Manufacturing (CMC) · Supplement 61 · priorityAP
1996-06-18Manufacturing (CMC) · Supplement 60 · priorityAP
1995-05-10Labeling · Supplement 25AP
1993-06-18Labeling · Supplement 28AP
1993-03-23Manufacturing (CMC) · Supplement 58 · priorityAP
1992-12-31Labeling · Supplement 57 · standardAP
1992-10-14Labeling · Supplement 29AP
1991-06-13Labeling · Supplement 27AP
1986-03-12Labeling · Supplement 21AP
1986-03-12Labeling · Supplement 22AP
1984-09-07Manufacturing (CMC) · Supplement 17 · priorityAP
1984-02-28Manufacturing (CMC) · Supplement 16 · priorityAP
1983-09-06Labeling · Supplement 14AP
1983-08-24Labeling · Supplement 13AP
1983-08-05Labeling · Supplement 12AP
1983-06-21Labeling · Supplement 10AP
1983-06-20Labeling · Supplement 9AP
1983-03-23Labeling · Supplement 7AP
1983-03-18Labeling · Supplement 6AP
1983-02-17Manufacturing (CMC) · Supplement 5 · priorityAP
1983-02-01Manufacturing (CMC) · Supplement 4 · priorityAP
1982-12-14Manufacturing (CMC) · Supplement 3 · priorityAP
1982-11-18Manufacturing (CMC) · Supplement 2 · priorityAP
1982-11-17Manufacturing (CMC) · Supplement 1 · priorityAP
1982-09-03Labeling · Supplement 26AP
1982-07-29Labeling · Supplement 23AP
1982-07-15Labeling · Supplement 19AP
1981-11-19Manufacturing (CMC) · Supplement 8 · priorityAP
1981-11-16Labeling · Supplement 55AP
1981-09-04Labeling · Supplement 54AP
1981-02-11Manufacturing (CMC) · Supplement 53 · priorityAP
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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