APPLICATION
ANDA065431
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-25
LATEST ACTION
2016-05-12
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 250MG/5ML, CLAVULANATE POTASSIUM EQ 62.5MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2016-05-12Labeling · Supplement 7 · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.