APPLICATION
ANDA065255
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-29
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 875MG · TABLET · ORAL
Approval history
2024-05-01Labeling · Supplement 28 · standardAP
2024-04-25Labeling · Supplement 25 · standardAP
2014-12-02Labeling · Supplement 9 · standardAP
2013-03-07Labeling · Supplement 8AP
2009-03-31Labeling · Supplement 3AP
2006-03-29OriginalAP
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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