APPLICATION
ANDA065358
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-13
LATEST ACTION
2026-01-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2026-01-05Labeling · Supplement 28 · standardAP
2024-06-24Labeling · Supplement 23 · standardAP
2023-10-23Labeling · Supplement 20 · standardAP
2020-01-27Labeling · Supplement 10 · standardAP
2014-10-29Labeling · Supplement 3AP
2012-01-30Labeling · Supplement 4AP
2007-08-13OriginalAP
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.
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