APPLICATION
ANDA065334
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-28
LATEST ACTION
2025-09-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 400MG/5ML · FOR SUSPENSION · ORAL
AMOXICILLINPrescription
AMOXICILLIN 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2025-09-17Labeling · Supplement 26 · standardAP
2024-05-01Labeling · Supplement 25 · standardAP
2024-04-09Labeling · Supplement 11 · standardAP
2024-04-09Labeling · Supplement 14 · standardAP
2024-04-09Labeling · Supplement 20 · standardAP
2024-04-09Labeling · Supplement 12 · standardAP
2012-12-03Labeling · Supplement 4AP
2012-11-26Labeling · Supplement 2AP
2006-12-28OriginalAP
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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