APPLICATION
ANDA062560
TYPE
ANDA
ORIGINAL APPROVAL
1985-09-10
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
MANDOLDiscontinued
CEFAMANDOLE NAFATE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 3AP
2007-12-07Labeling · Supplement 2AP
1992-11-23Manufacturing (CMC) · Supplement 4AP
1992-10-30Manufacturing (CMC) · Supplement 5AP
1985-09-10OriginalAP
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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