← FDA DRUG APPROVALS

FDA NDA · NDA050564

AUGMENTIN '250'

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050564
TYPE
NDA
ORIGINAL APPROVAL
1984-08-06
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AUGMENTIN '250' · ReferenceDiscontinued
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AUGMENTIN '500' · ReferenceDiscontinued
AMOXICILLIN 500MG, CLAVULANATE POTASSIUM EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-07-17Labeling · Supplement 61 · standard — Label ↗AP
2024-05-01Labeling · Supplement 60 · standard — Letter ↗AP
2022-08-25Labeling · Supplement 59 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 57 · priorityAP
2013-01-22Labeling · Supplement 55 · standard — Label ↗AP
2013-01-22Labeling · Supplement 53 · standard — Letter ↗AP
2011-09-29Labeling · Supplement 52 · standard — Label ↗AP
2008-12-04Labeling · Supplement 50 · standard — Label ↗AP
2008-06-09Labeling · Supplement 49 · standard — Letter ↗AP
2008-03-26Labeling · Supplement 51 · standard — Label ↗AP
2005-08-05Labeling · Supplement 48 · standard — Letter ↗AP
2004-08-30Labeling · Supplement 47 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 46 · standard — Letter ↗AP
2003-07-25Labeling · Supplement 43 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 44 · priorityAP
2002-10-17Manufacturing (CMC) · Supplement 45 · priorityAP
2002-05-01Manufacturing (CMC) · Supplement 41 · priorityAP
2002-04-10Labeling · Supplement 34 · standard — Letter ↗AP
2001-05-03Manufacturing (CMC) · Supplement 39 · priorityAP
2001-04-17Manufacturing (CMC) · Supplement 40 · priorityAP
1999-11-19Manufacturing (CMC) · Supplement 37 · priorityAP
1999-09-23Manufacturing (CMC) · Supplement 36 · priorityAP
1999-02-01Manufacturing (CMC) · Supplement 35 · priorityAP
1998-02-12Manufacturing (CMC) · Supplement 33 · priorityAP
1998-02-11Labeling · Supplement 32 · standardAP
1997-03-19Labeling · Supplement 31 · standardAP
1996-03-04Labeling · Supplement 26 · standardAP
1996-02-16Labeling · Supplement 22 · standard — Review ↗AP
1994-09-15Manufacturing (CMC) · Supplement 23 · priorityAP
1994-07-06Labeling · Supplement 25 · standardAP
1994-06-21Manufacturing (CMC) · Supplement 24 · priorityAP
1992-09-16Manufacturing (CMC) · Supplement 17 · priorityAP
1992-07-21Labeling · Supplement 21AP
1992-06-22Manufacturing (CMC) · Supplement 19 · priorityAP
1992-05-21Manufacturing (CMC) · Supplement 20 · priorityAP
1991-12-14Labeling · Supplement 16AP
1991-11-22Manufacturing (CMC) · Supplement 18 · priorityAP
1990-05-22Manufacturing (CMC) · Supplement 14 · priorityAP
1989-03-09Labeling · Supplement 12AP
1989-02-07Manufacturing (CMC) · Supplement 11 · priorityAP
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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