APPLICATION
ANDA065189
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-23
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 30 · standardAP
2024-04-29Labeling · Supplement 28 · standardAP
2014-09-22Labeling · Supplement 16 · standardAP
2014-09-22Labeling · Supplement 14 · standardAP
2014-09-22Labeling · Supplement 15 · standardAP
2006-09-26Labeling · Supplement 6AP
2006-07-31Labeling · Supplement 4AP
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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