APPLICATION
ANDA063002
TYPE
ANDA
ORIGINAL APPROVAL
1991-03-28
LATEST ACTION
2016-02-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ANCEF IN PLASTIC CONTAINERDiscontinued
CEFAZOLIN SODIUM EQ 20MG BASE/ML · INJECTABLE · INJECTION
ANCEF IN PLASTIC CONTAINERDiscontinued
CEFAZOLIN SODIUM EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2016-02-29Labeling · Supplement 15 · standardAP
2013-03-22Labeling · Supplement 10AP
2008-04-30Labeling · Supplement 7AP
2004-10-07Labeling · Supplement 6AP
2001-03-06Manufacturing (CMC) · Supplement 3AP
1994-07-27Manufacturing (CMC) · Supplement 2AP
1992-12-21Manufacturing (CMC) · Supplement 1AP
1991-03-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.