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FDA NDA · NDA050597

AUGMENTIN '125'

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050597
TYPE
NDA
ORIGINAL APPROVAL
1985-07-22
LATEST ACTION
2026-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

AUGMENTIN '125' · ReferenceDiscontinued
AMOXICILLIN 125MG, CLAVULANATE POTASSIUM EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
AUGMENTIN '250' · ReferenceDiscontinued
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2026-07-17Labeling · Supplement 53 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 52 · standard — Letter ↗AP
2022-08-25Labeling · Supplement 51 · standard — Letter ↗AP
2013-01-22Labeling · Supplement 49 · unknown — Label ↗AP
2013-01-22Labeling · Supplement 47 · standard — Label ↗AP
2011-09-29Labeling · Supplement 46 · standard — Label ↗AP
2008-12-04Labeling · Supplement 44 · standard — Label ↗AP
2008-03-27Labeling · Supplement 45 · standard — Label ↗AP
2004-08-11Labeling · Supplement 43 · standard — Letter ↗AP
2004-06-03Labeling · Supplement 42 · standard — Letter ↗AP
2003-05-12Labeling · Supplement 39 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 40 · standardAP
2002-10-17Manufacturing (CMC) · Supplement 41 · standardAP
2002-04-10Labeling · Supplement 30 · standard — Letter ↗AP
2002-03-28Manufacturing (CMC) · Supplement 37 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 36 · standardAP
2001-03-29Manufacturing (CMC) · Supplement 35 · standardAP
1999-11-19Manufacturing (CMC) · Supplement 33 · standardAP
1999-09-23Manufacturing (CMC) · Supplement 32 · standardAP
1999-02-01Manufacturing (CMC) · Supplement 31 · standardAP
1998-02-19Manufacturing (CMC) · Supplement 29 · standardAP
1998-02-11Labeling · Supplement 28 · standardAP
1997-03-19Labeling · Supplement 27 · standardAP
1996-03-04Labeling · Supplement 24 · standardAP
1996-02-16Labeling · Supplement 20 · standardAP
1994-09-15Manufacturing (CMC) · Supplement 21 · standardAP
1994-07-06Labeling · Supplement 23 · standardAP
1994-06-21Manufacturing (CMC) · Supplement 22 · standardAP
1992-09-16Manufacturing (CMC) · Supplement 16 · standardAP
1992-07-21Labeling · Supplement 19AP
1992-05-04Manufacturing (CMC) · Supplement 18 · standardAP
1991-12-05Labeling · Supplement 15AP
1991-11-22Manufacturing (CMC) · Supplement 17 · standardAP
1991-10-25Manufacturing (CMC) · Supplement 11 · standardAP
1991-05-22Manufacturing (CMC) · Supplement 14 · standardAP
1989-10-04Manufacturing (CMC) · Supplement 8 · standardAP
1989-07-02Efficacy · Supplement 12AP
1989-03-09Labeling · Supplement 13AP
1988-09-20Manufacturing (CMC) · Supplement 10 · standardAP
1988-05-05Labeling · Supplement 9AP
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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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