← FDA DRUG APPROVALS

FDA ANDA · ANDA065248

CEPHALEXIN

Sponsor: ANDA REPOSITORY

APPLICATION
ANDA065248
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-28
LATEST ACTION
2011-09-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

CEPHALEXINPrescription
CEPHALEXIN EQ 250MG BASE · CAPSULE · ORAL
CEPHALEXINPrescription
CEPHALEXIN EQ 500MG BASE · CAPSULE · ORAL

Approval history

2011-09-29Labeling · Supplement 8AP
2006-03-08Labeling · Supplement 3AP
2005-06-28OriginalAP
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 →