APPLICATION
ANDA061926
TYPE
ANDA
ORIGINAL APPROVAL
1976-02-09
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 500MG · CAPSULE · ORAL
AMOXICILLINPrescription
AMOXICILLIN 250MG · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 136 · standardAP
2024-01-03Labeling · Supplement 132 · standardAP
2019-12-04Labeling · Supplement 131 · standardAP
2017-05-18Labeling · Supplement 128 · standardAP
2017-05-18Labeling · Supplement 127 · standardAP
2015-09-10Labeling · Supplement 121AP
2009-02-02Labeling · Supplement 117AP
2008-07-17Labeling · Supplement 116AP
2007-05-31Labeling · Supplement 113AP
2003-07-30Labeling · Supplement 110AP
2002-11-20Manufacturing (CMC) · Supplement 106AP
2002-11-20Manufacturing (CMC) · Supplement 105AP
2002-04-19Manufacturing (CMC) · Supplement 100AP
2002-04-19Manufacturing (CMC) · Supplement 101AP
2002-03-14Manufacturing (CMC) · Supplement 102AP
2001-09-17Manufacturing (CMC) · Supplement 98AP
2001-07-24Manufacturing (CMC) · Supplement 96AP
2001-07-13Labeling · Supplement 99AP
2001-05-15Manufacturing (CMC) · Supplement 95AP
2001-03-23Labeling · Supplement 97AP
2001-01-04Manufacturing (CMC) · Supplement 94AP
2000-07-07Manufacturing (CMC) · Supplement 93AP
1999-04-06Labeling · Supplement 91AP
1997-12-10Manufacturing (CMC) · Supplement 90AP
1997-06-09Manufacturing (CMC) · Supplement 89AP
1996-08-27Manufacturing (CMC) · Supplement 88AP
1996-05-08Manufacturing (CMC) · Supplement 87AP
1995-06-30Manufacturing (CMC) · Supplement 86AP
1993-11-26Labeling · Supplement 85AP
1993-09-02Manufacturing (CMC) · Supplement 82AP
1993-06-28Labeling · Supplement 83AP
1992-08-14Labeling · Supplement 81AP
1989-03-28Manufacturing (CMC) · Supplement 79AP
1976-02-09OriginalAP
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.