APPLICATION
ANDA065333
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-24
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 500MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMDiscontinued
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-11-26Labeling · Supplement 6 · standardAP
2024-05-01Labeling · Supplement 4 · standardAP
2024-04-15Labeling · Supplement 3 · standardAP
2014-10-31Labeling · Supplement 1AP
2014-10-31Labeling · Supplement 2 · standardAP
2009-02-24OriginalAP
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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