APPLICATION
ANDA065066
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-05
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 400MG/5ML, CLAVULANATE POTASSIUM EQ 57MG BASE/5ML · FOR SUSPENSION · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 200MG/5ML, CLAVULANATE POTASSIUM EQ 28.5MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 50 · standardAP
2024-04-29Labeling · Supplement 45 · standardAP
2014-11-25Labeling · Supplement 19AP
2014-09-22Labeling · Supplement 34 · standardAP
2014-09-22Labeling · Supplement 32 · standardAP
2014-09-22Labeling · Supplement 29 · standardAP
2011-06-28Labeling · Supplement 28AP
2009-05-29Labeling · Supplement 23AP
2007-01-14Labeling · Supplement 18AP
2005-06-02Labeling · Supplement 10AP
2002-11-26Manufacturing (CMC) · Supplement 1AP
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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