APPLICATION
ANDA065191
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-25
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 35 · standardAP
2024-04-23Labeling · Supplement 32 · standardAP
2014-11-03Labeling · Supplement 14 · standardAP
2014-11-03Labeling · Supplement 13AP
2011-01-27Labeling · Supplement 6AP
2011-01-27Labeling · Supplement 9AP
2009-08-31Labeling · Supplement 7AP
2005-01-25OriginalAP
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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