← FDA DRUG APPROVALS
FDA ANDA · ANDA065161
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA065161
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-03
LATEST ACTION
2008-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 400MG, CLAVULANATE POTASSIUM EQ 57MG BASE · TABLET, CHEWABLE · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 200MG, CLAVULANATE POTASSIUM EQ 28.5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2008-05-28Labeling · Supplement 8AP
2007-10-26Labeling · Supplement 4AP
2006-03-08Labeling · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.