← FDA DRUG APPROVALS

FDA ANDA · ANDA065323

CEFUROXIME AXETIL

Sponsor: SUN PHARM INDS LTD

APPLICATION
ANDA065323
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-05
LATEST ACTION
2008-02-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
CEFUROXIME AXETILDiscontinued
CEFUROXIME AXETIL EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2008-02-05OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →