APPLICATION
ANDA061931
TYPE
ANDA
ORIGINAL APPROVAL
1982-12-01
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription, Discontinued
Products
AMOXICILLINPrescription
AMOXICILLIN 250MG/5ML · FOR SUSPENSION · ORAL
AMOXICILLIN PEDIATRICPrescription
AMOXICILLIN 50MG/ML · FOR SUSPENSION · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 125MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 60 · standardAP
2024-01-03Labeling · Supplement 56 · standardAP
2019-12-04Labeling · Supplement 52 · standardAP
2017-05-18Labeling · Supplement 48 · standardAP
2017-05-18Labeling · Supplement 49 · standardAP
2015-09-10Labeling · Supplement 42AP
2009-02-02Labeling · Supplement 40AP
2008-07-17Labeling · Supplement 39AP
2007-05-31Labeling · Supplement 38AP
2004-04-19Labeling · Supplement 30AP
2002-11-07Manufacturing (CMC) · Supplement 24AP
2002-11-07Manufacturing (CMC) · Supplement 25AP
2002-11-07Manufacturing (CMC) · Supplement 15AP
2002-05-24Manufacturing (CMC) · Supplement 22AP
2002-03-14Manufacturing (CMC) · Supplement 21AP
2001-07-13Labeling · Supplement 20AP
2001-05-15Manufacturing (CMC) · Supplement 18AP
2001-03-23Labeling · Supplement 19AP
2000-11-14Manufacturing (CMC) · Supplement 17AP
2000-07-07Manufacturing (CMC) · Supplement 16AP
1999-04-06Labeling · Supplement 14AP
1997-12-22Manufacturing (CMC) · Supplement 13AP
1997-02-18Manufacturing (CMC) · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 11AP
1996-07-02Manufacturing (CMC) · Supplement 10AP
1996-03-27Manufacturing (CMC) · Supplement 8AP
1996-03-25Manufacturing (CMC) · Supplement 9AP
1995-09-18Manufacturing (CMC) · Supplement 7AP
1995-07-17Manufacturing (CMC) · Supplement 5AP
1995-01-06Manufacturing (CMC) · Supplement 6AP
1994-03-14Manufacturing (CMC) · Supplement 2AP
1993-06-29Labeling · Supplement 3AP
1982-12-01OriginalAP
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.