APPLICATION
ANDA065065
TYPE
ANDA
ORIGINAL APPROVAL
2002-04-18
LATEST ACTION
2025-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 400MG, CLAVULANATE POTASSIUM EQ 57MG BASE · TABLET, CHEWABLE · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 200MG, CLAVULANATE POTASSIUM EQ 28.5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2025-07-25Labeling · Supplement 36 · standardAP
2024-05-01Labeling · Supplement 35 · standardAP
2024-04-29Labeling · Supplement 34 · standardAP
2014-09-22Labeling · Supplement 30 · standardAP
2014-09-22Labeling · Supplement 29 · standardAP
2014-09-22Labeling · Supplement 26 · standardAP
2011-06-28Labeling · Supplement 25AP
2009-05-29Labeling · Supplement 22AP
2008-01-31Labeling · Supplement 19AP
2007-01-03Labeling · Supplement 18AP
2005-06-02Labeling · Supplement 12AP
2002-09-13Manufacturing (CMC) · Supplement 4AP
2002-08-21Manufacturing (CMC) · Supplement 2AP
2002-08-21Manufacturing (CMC) · Supplement 3AP
2002-08-21Manufacturing (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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