APPLICATION
ANDA065228
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-13
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 875MG · TABLET · ORAL
AMOXICILLINPrescription
AMOXICILLIN 500MG · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 20 · standardAP
2024-04-25Labeling · Supplement 19 · standardAP
2024-04-25Labeling · Supplement 17 · standardAP
2020-06-03Labeling · Supplement 11 · standardAP
2020-06-03Labeling · Supplement 12 · standardAP
2014-11-25Labeling · Supplement 7 · standardAP
2013-02-22Labeling · Supplement 6 · standardAP
2005-07-13OriginalAP
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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