APPLICATION
ANDA065205
TYPE
ANDA
ORIGINAL APPROVAL
2005-02-09
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 400MG, CLAVULANATE POTASSIUM EQ 57MG BASE · TABLET, CHEWABLE · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 200MG, CLAVULANATE POTASSIUM EQ 28.5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2024-05-01Labeling · Supplement 30 · standardAP
2024-04-24Labeling · Supplement 26 · standardAP
2024-04-24Labeling · Supplement 19 · standardAP
2014-10-20Manufacturing (CMC) · Supplement 13AP
2014-09-26Labeling · Supplement 17 · standardAP
2013-07-24Labeling · Supplement 8AP
2013-07-08Labeling · Supplement 15 · standardAP
2011-07-29Labeling · Supplement 7AP
2010-07-20Labeling · Supplement 6AP
2009-10-28Labeling · Supplement 5AP
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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