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FDA ANDA · ANDA091569
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA091569
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-20
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 500MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-11-26Labeling · Supplement 23 · standardAP
2024-05-06Labeling · Supplement 22 · standardAP
2024-05-06Labeling · Supplement 17 · standardAP
2024-05-06Labeling · Supplement 13 · standardAP
2020-04-03Labeling · Supplement 9 · standardAP
2015-07-23Labeling · Supplement 2 · standardAP
2012-01-20OriginalAP
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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