← FDA DRUG APPROVALS

FDA NDA · NDA050575

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050575
TYPE
NDA
ORIGINAL APPROVAL
1984-08-06
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

AUGMENTIN '125' · ReferencePrescription
AMOXICILLIN 125MG/5ML, CLAVULANATE POTASSIUM EQ 31.25MG BASE/5ML · FOR SUSPENSION · ORAL
AUGMENTIN '250' · ReferencePrescription
AMOXICILLIN 250MG/5ML, CLAVULANATE POTASSIUM EQ 62.5MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2026-07-17Labeling · Supplement 53 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 51 · standard — Letter ↗AP
2022-08-25Labeling · Supplement 48 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 44 · standardAP
2013-01-22Labeling · Supplement 42 · unknown — Label ↗AP
2013-01-22Labeling · Supplement 40 · standard — Letter ↗AP
2011-09-29Labeling · Supplement 39 · standard — Label ↗AP
2008-12-04Labeling · Supplement 37 · standard — Label ↗AP
2008-03-27Labeling · Supplement 38 · standard — Letter ↗AP
2004-08-11Labeling · Supplement 36 · standard — Letter ↗AP
2004-06-03Labeling · Supplement 35 · standard — Letter ↗AP
2003-05-12Labeling · Supplement 32 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 33 · standardAP
2002-10-17Manufacturing (CMC) · Supplement 34 · standardAP
2002-04-10Labeling · Supplement 25 · standard — Letter ↗AP
2001-04-17Manufacturing (CMC) · Supplement 30 · standardAP
1999-11-19Manufacturing (CMC) · Supplement 28 · standardAP
1999-09-23Manufacturing (CMC) · Supplement 27 · standardAP
1999-02-01Manufacturing (CMC) · Supplement 26 · standardAP
1998-02-11Manufacturing (CMC) · Supplement 24 · standardAP
1998-02-11Labeling · Supplement 23 · standardAP
1997-03-19Labeling · Supplement 22 · standardAP
1996-03-04Labeling · Supplement 19 · standardAP
1996-02-16Labeling · Supplement 16 · standard — Review ↗AP
1994-09-15Manufacturing (CMC) · Supplement 17 · standardAP
1994-07-06Labeling · Supplement 18 · standardAP
1994-04-18Manufacturing (CMC) · Supplement 13 · standardAP
1992-07-21Labeling · Supplement 15AP
1991-12-05Labeling · Supplement 12AP
1991-11-05Manufacturing (CMC) · Supplement 14 · standardAP
1991-05-22Manufacturing (CMC) · Supplement 11 · standardAP
1984-08-06Type 3 - New Dosage Form · Original · standardAP
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 →