APPLICATION
ANDA065063
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-14
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 875MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 51 · standardAP
2024-04-29Labeling · Supplement 48 · standardAP
2022-09-01Manufacturing (CMC) · Supplement 46 · unknownAP
2014-09-22Labeling · Supplement 32 · standardAP
2014-09-22Labeling · Supplement 35 · standardAP
2014-09-22Labeling · Supplement 34 · standardAP
2006-09-26Labeling · Supplement 23AP
2006-07-31Labeling · Supplement 22AP
2005-06-02Labeling · Supplement 12AP
2002-09-13Manufacturing (CMC) · Supplement 4AP
2002-08-21Manufacturing (CMC) · Supplement 2AP
2002-08-21Manufacturing (CMC) · Supplement 3AP
2002-08-21Manufacturing (CMC) · Supplement 1AP
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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