APPLICATION
ANDA062059
TYPE
ANDA
ORIGINAL APPROVAL
1978-12-08
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
AMOXICILLINDiscontinued
AMOXICILLIN 125MG/5ML · FOR SUSPENSION · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 250MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 6 · standardAP
2023-01-18Labeling · Supplement 4 · standardAP
2016-01-26Manufacturing (CMC) · Supplement 3AP
1997-07-15Labeling · Supplement 1AP
1978-12-08OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.