APPLICATION
ANDA065319
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-18
LATEST ACTION
2021-01-14
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 400MG/5ML · FOR SUSPENSION · ORAL
Approval history
2021-01-14Labeling · Supplement 3 · standardAP
2021-01-14Labeling · Supplement 2 · standardAP
2014-12-02Labeling · Supplement 1 · standardAP
2007-06-18OriginalAP
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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