APPLICATION
ANDA065056
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-18
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 500MG · TABLET · ORAL
AMOXICILLINPrescription
AMOXICILLIN 875MG · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 26 · standardAP
2024-01-03Labeling · Supplement 21 · standardAP
2014-10-22Manufacturing (CMC) · Supplement 20AP
2009-02-25Labeling · Supplement 14AP
2002-08-20Manufacturing (CMC) · Supplement 5AP
2002-08-20Manufacturing (CMC) · Supplement 6AP
2002-06-28Manufacturing (CMC) · Supplement 3AP
2001-10-24Manufacturing (CMC) · Supplement 2AP
2001-05-15Manufacturing (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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