← FDA DRUG APPROVALS

FDA NDA · NDA050755

AUGMENTIN ES-600

amoxicillin and clavulanate potassium

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050755
TYPE
NDA
ORIGINAL APPROVAL
2001-06-22
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

AUGMENTIN ES-600 · ReferencePrescription
AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2026-07-17Labeling · Supplement 32 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 31 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 29 · standard — Letter ↗AP
2022-09-22Labeling · Supplement 25 · standard — Label ↗AP
2022-06-30Labeling · Supplement 24 · standard — Letter ↗AP
2015-03-16Labeling · Supplement 22 · standard — Label ↗AP
2014-09-30Manufacturing (CMC) · Supplement 21 · standardAP
2014-04-08Manufacturing (CMC) · Supplement 20 · standardAP
2011-08-26Labeling · Supplement 18 · standard — Label ↗AP
2011-08-26Labeling · Supplement 16 · standard — Label ↗AP
2009-01-16Labeling · Supplement 14 · standard — Label ↗AP
2008-04-17Labeling · Supplement 15 · standard — Letter ↗AP
2004-12-17Efficacy · Supplement 12 · unknown — Label ↗AP
2004-11-10Labeling · Supplement 11 · standard — Letter ↗AP
2004-06-03Labeling · Supplement 10 · standard — Label ↗AP
2003-05-12Labeling · Supplement 3 · standard — Review ↗AP
2002-12-04Manufacturing (CMC) · Supplement 4 · standardAP
2002-11-27Manufacturing (CMC) · Supplement 1 · standardAP
2002-10-17Manufacturing (CMC) · Supplement 5 · standardAP
2001-06-22Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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