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FDA ANDA · ANDA091568

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA091568
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 875MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL

Approval history

2024-11-26Labeling · Supplement 25 · standardAP
2024-05-06Labeling · Supplement 11 · standardAP
2024-05-06Labeling · Supplement 18 · standardAP
2024-05-06Labeling · Supplement 24 · standardAP
2024-05-06Labeling · Supplement 14 · standardAP
2015-07-23Labeling · Supplement 2 · standardAP
2012-01-20OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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