← FDA DRUG APPROVALS

FDA NDA · NDA050460

AMOXIL

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA050460
TYPE
NDA
ORIGINAL APPROVAL
1974-01-18
LATEST ACTION
1974-01-18
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

AMOXIL · ReferenceDiscontinued
AMOXICILLIN 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
LAROTID · ReferenceDiscontinued
AMOXICILLIN 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
AMOXIL · ReferenceDiscontinued
AMOXICILLIN 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL
AMOXIL · ReferenceDiscontinued
AMOXICILLIN 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

1974-01-18Type 3 - New Dosage Form · Original · priorityAP
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 →