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FDA ANDA · ANDA065132
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA065132
TYPE
ANDA
ORIGINAL APPROVAL
2003-03-19
LATEST ACTION
2008-05-28
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 200MG/5ML, CLAVULANATE POTASSIUM EQ 28.5MG BASE/5ML · FOR SUSPENSION · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 400MG/5ML, CLAVULANATE POTASSIUM EQ 57MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2008-05-28Labeling · Supplement 11AP
2007-10-26Labeling · Supplement 5AP
2006-03-08Labeling · Supplement 4AP
2004-07-21Labeling · Supplement 2AP
2003-03-19OriginalAP
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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