← FDA DRUG APPROVALS

FDA NDA · NDA050761

AMOXIL

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050761
TYPE
NDA
ORIGINAL APPROVAL
1999-04-15
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

AMOXILDiscontinued
AMOXICILLIN 400MG · TABLET, CHEWABLE · ORAL
AMOXILDiscontinued
AMOXICILLIN 200MG · TABLET, CHEWABLE · ORAL

Approval history

2024-05-01Labeling · Supplement 19 · standard — Label ↗AP
2022-11-02Labeling · Supplement 18 · standard — Label ↗AP
2015-12-03Labeling · Supplement 17 · standard — Label ↗AP
2015-09-24Labeling · Supplement 16 · standard — Letter ↗AP
2011-11-16Labeling · Supplement 12 · standard — Letter ↗AP
2011-11-16Labeling · Supplement 15 · unknown — Letter ↗AP
2011-11-16Labeling · Supplement 13 · standard — Letter ↗AP
2008-06-09Labeling · Supplement 10 · standard — Label ↗AP
2008-03-28Labeling · Supplement 11 · standard — Label ↗AP
2006-01-26Labeling · Supplement 9 · standard — Letter ↗AP
2004-07-13Labeling · Supplement 8 · standard — Letter ↗AP
2003-12-18Labeling · Supplement 7 · standard — Letter ↗AP
2003-05-12Labeling · Supplement 3 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 6 · standardAP
2002-05-01Manufacturing (CMC) · Supplement 5 · standardAP
2002-04-25Manufacturing (CMC) · Supplement 4 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 2 · standardAP
2000-05-16Labeling · Supplement 1 · standard — Review ↗AP
1999-04-15Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →