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FDA ANDA · ANDA201090
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA201090
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-20
LATEST ACTION
2026-02-15
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
2026-02-15Labeling · Supplement 15 · standardAP
2024-05-01Labeling · Supplement 14 · standardAP
2024-04-25Labeling · Supplement 5 · standardAP
2024-04-25Labeling · Supplement 11 · standardAP
2015-02-09Labeling · Supplement 2 · standardAP
2011-12-20Not Applicable · OriginalAP
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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