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FDA ANDA · ANDA201091
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA201091
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-20
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 13 · standardAP
2024-04-11Labeling · Supplement 10 · standardAP
2024-04-11Labeling · Supplement 4 · standardAP
2024-04-11Labeling · 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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