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FDA NDA · NDA050542

AMOXIL

Sponsor: US ANTIBIOTICS

APPLICATION
NDA050542
TYPE
NDA
ORIGINAL APPROVAL
1980-10-21
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

AMOXIL · ReferenceDiscontinued
AMOXICILLIN 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL
AMOXIL · ReferenceDiscontinued
AMOXICILLIN 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, CHEWABLE · ORAL

Approval history

2024-05-01Labeling · Supplement 32 · standard — Letter ↗AP
2022-11-02Labeling · Supplement 31 · standard — Letter ↗AP
2015-12-03Labeling · Supplement 30 · standard — Label ↗AP
2015-09-24Labeling · Supplement 29 · standard — Label ↗AP
2011-11-16Labeling · Supplement 28 · unknown — Label ↗AP
2011-11-16Labeling · Supplement 26 · standard — Label ↗AP
2011-11-16Labeling · Supplement 27 · standard — Letter ↗AP
2008-06-09Labeling · Supplement 24 · standard — Letter ↗AP
2008-03-28Labeling · Supplement 25 · standard — Label ↗AP
2006-01-26Labeling · Supplement 23 · standardAP
2004-07-13Labeling · Supplement 22 · standard — Letter ↗AP
2003-12-18Labeling · Supplement 21 · standard — Letter ↗AP
2003-05-12Labeling · Supplement 19 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 20 · standardAP
2002-04-10Labeling · Supplement 16 · standard — Review ↗AP
2001-04-17Manufacturing (CMC) · Supplement 18 · standardAP
2000-05-16Labeling · Supplement 17 · standard — Review ↗AP
1998-02-27Labeling · Supplement 10 · standard — Review ↗AP
1998-02-27Labeling · Supplement 5 — Review ↗AP
1998-02-27Efficacy · Supplement 11 · standard — Review ↗AP
1998-02-12Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-10Labeling · Supplement 8 · standardAP
1993-09-13Labeling · Supplement 7 · standardAP
1991-04-23Manufacturing (CMC) · Supplement 4 · standardAP
1991-04-10Labeling · Supplement 6AP
1989-02-08Manufacturing (CMC) · Supplement 3 · standardAP
1988-09-12Labeling · Supplement 2AP
1985-12-17Labeling · Supplement 1AP
1980-10-21Type 3 - New Dosage Form · Original · standardAP
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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