← FDA DRUG APPROVALS

FDA ANDA · ANDA065319

AMOXICILLIN

Sponsor: CHARTWELL RX

APPLICATION
ANDA065319
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-18
LATEST ACTION
2021-01-14
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

AMOXICILLINPrescription
AMOXICILLIN 400MG/5ML · FOR SUSPENSION · ORAL

Approval history

2021-01-14Labeling · Supplement 3 · standardAP
2021-01-14Labeling · Supplement 2 · standardAP
2014-12-02Labeling · Supplement 1 · standardAP
2007-06-18OriginalAP
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 →