← FDA DRUG APPROVALS

FDA ANDA · ANDA091036

CEFADROXIL

Sponsor: HIKMA PHARMS

APPLICATION
ANDA091036
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-28
LATEST ACTION
2015-12-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML · FOR SUSPENSION · ORAL
CEFADROXILDiscontinued
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2015-12-17Labeling · Supplement 5 · standardAP
2015-12-17Labeling · Supplement 4 · standardAP
2012-11-28OriginalAP
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 →