APPLICATION
ANDA065325
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-19
LATEST ACTION
2024-05-01
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
2024-05-01Labeling · Supplement 35 · standardAP
2024-04-25Labeling · Supplement 32 · standardAP
2014-12-02Labeling · Supplement 16 · standardAP
2014-12-02Labeling · Supplement 17 · standardAP
2013-03-07Labeling · Supplement 11AP
2008-10-30Labeling · Supplement 3AP
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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