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FDA ANDA · ANDA065324

AMOXICILLIN

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA065324
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-17
LATEST ACTION
2014-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

AMOXICILLINDiscontinued
AMOXICILLIN 200MG · TABLET, FOR SUSPENSION · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 400MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2014-12-02Labeling · Supplement 6AP
2007-01-17OriginalAP
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