APPLICATION
ANDA217805
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-08
LATEST ACTION
2025-03-13
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2025-03-13Labeling · Supplement 2 · standardAP
2024-07-11Labeling · Supplement 1 · standardAP
2023-12-08UNKNOWN · Original · standardAP
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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