APPLICATION
ANDA065089
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 200MG/5ML, CLAVULANATE POTASSIUM EQ 28.5MG BASE/5ML · FOR SUSPENSION · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 400MG/5ML, CLAVULANATE POTASSIUM EQ 57MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 30 · standardAP
2024-04-24Labeling · Supplement 21 · standardAP
2024-04-24Labeling · Supplement 26 · standardAP
2014-09-26Labeling · Supplement 17 · standardAP
2013-07-25Labeling · Supplement 15 · standardAP
2012-06-04Labeling · Supplement 11AP
2009-03-12Labeling · Supplement 8AP
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.