← FDA DRUG APPROVALS

FDA NDA · NDA050785

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050785
TYPE
NDA
ORIGINAL APPROVAL
2002-09-25
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AUGMENTIN XR · ReferencePrescription
AMOXICILLIN 1GM, CLAVULANATE POTASSIUM EQ 62.5MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-17Labeling · Supplement 22 · standard — Letter ↗AP
2024-12-20Labeling · Supplement 19 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 18 · standard — Letter ↗AP
2022-11-02Labeling · Supplement 17 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 16 · standardAP
2014-04-04Labeling · Supplement 15 · standard — Letter ↗AP
2013-11-27Labeling · Supplement 14 · standard — Letter ↗AP
2011-08-26Labeling · Supplement 9 · standard — Label ↗AP
2010-08-27Labeling · Supplement 12 · unknown — Label ↗AP
2010-08-27Labeling · Supplement 11 · standard — Label ↗AP
2008-12-10Labeling · Supplement 7 · standard — Letter ↗AP
2008-04-17Labeling · Supplement 8 · standard — Letter ↗AP
2005-06-15Efficacy · Supplement 6 · standard — Label ↗AP
2004-09-16Labeling · Supplement 5 · standard — Letter ↗AP
2004-05-24Labeling · Supplement 4 · standard — Letter ↗AP
2003-05-30Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2003-05-20Labeling · Supplement 2 · standard — Letter ↗AP
2002-09-25Type 3 - New Dosage Form · Original · standard — Review ↗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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