← FDA DRUG APPROVALS

FDA ANDA · ANDA062592

KEFUROX

Sponsor: LILLY

APPLICATION
ANDA062592
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-10
LATEST ACTION
2002-11-12
ROUTE
INJECTION, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

KEFUROXDiscontinued
CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
KEFUROXDiscontinued
CEFUROXIME SODIUM EQ 750MG BASE/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2002-11-12Labeling · Supplement 26AP
2002-11-12Labeling · Supplement 24AP
2002-09-30Manufacturing (CMC) · Supplement 25AP
2002-09-04Manufacturing (CMC) · Supplement 23AP
2002-06-24Manufacturing (CMC) · Supplement 22AP
2001-09-05Manufacturing (CMC) · Supplement 21AP
2001-01-22Manufacturing (CMC) · Supplement 19AP
2001-01-22Manufacturing (CMC) · Supplement 17AP
2001-01-22Manufacturing (CMC) · Supplement 18AP
2001-01-22Labeling · Supplement 20AP
1997-01-23Labeling · Supplement 14AP
1997-01-23Manufacturing (CMC) · Supplement 12AP
1997-01-13Manufacturing (CMC) · Supplement 13AP
1996-08-15Manufacturing (CMC) · Supplement 15AP
1992-10-30Manufacturing (CMC) · Supplement 10AP
1992-06-12Labeling · Supplement 9AP
1992-06-12Manufacturing (CMC) · Supplement 5AP
1986-07-21Manufacturing (CMC) · Supplement 1AP
1986-01-10OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →