APPLICATION
ANDA065322
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-19
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 125MG/5ML · FOR SUSPENSION · ORAL
AMOXICILLINPrescription
AMOXICILLIN 250MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-06-12Labeling · Supplement 35 · standardAP
2024-06-12Labeling · Supplement 38 · standardAP
2024-05-01Labeling · Supplement 39 · standardAP
2014-12-02Labeling · Supplement 18 · standardAP
2013-03-07Labeling · Supplement 13AP
2008-10-30Labeling · Supplement 4AP
2006-06-19OriginalAP
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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