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FDA NDA · NDA050605

CEFTIN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA050605
TYPE
NDA
ORIGINAL APPROVAL
1987-12-28
LATEST ACTION
2021-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CEFTIN · ReferenceDiscontinued
CEFUROXIME AXETIL EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CEFTIN · ReferenceDiscontinued
CEFUROXIME AXETIL EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CEFTIN · ReferenceDiscontinued
CEFUROXIME AXETIL EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-03-05Labeling · Supplement 52 · standard — Letter ↗AP
2019-04-25Labeling · Supplement 51 · standard — Letter ↗AP
2017-10-13Labeling · Supplement 50 · standard — Label ↗AP
2016-11-22Labeling · Supplement 49 · standard — Letter ↗AP
2015-08-26Labeling · Supplement 48 · standard — Label ↗AP
2015-06-26Labeling · Supplement 47 · standard — Label ↗AP
2014-09-20Labeling · Supplement 46 · standard — Label ↗AP
2014-09-20Labeling · Supplement 43 · standard — Label ↗AP
2007-07-23Labeling · Supplement 42 · standard — Label ↗AP
2004-06-03Labeling · Supplement 39 · standard — Label ↗AP
2002-07-24Labeling · Supplement 37 · standard — Letter ↗AP
2002-04-11Labeling · Supplement 33 · standard — Letter ↗AP
2002-03-29Labeling · Supplement 31 · standard — Letter ↗AP
2001-12-20Manufacturing (CMC) · Supplement 36 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 34 · standardAP
2001-04-13Manufacturing (CMC) · Supplement 35 · standardAP
1999-08-24Efficacy · Supplement 32 · standard — Review ↗AP
1998-03-24Labeling · Supplement 30 · standardAP
1998-01-16Manufacturing (CMC) · Supplement 29 · standardAP
1997-11-19Manufacturing (CMC) · Supplement 28 · standardAP
1997-09-17Efficacy · Supplement 25 · standardAP
1997-06-04Labeling · Supplement 27 · standardAP
1996-12-23Labeling · Supplement 26 · standardAP
1996-12-23Labeling · Supplement 21 · standardAP
1996-12-19Efficacy · Supplement 17 · unknownAP
1996-12-06Efficacy · Supplement 24 · unknownAP
1996-09-13Labeling · Supplement 22 · standardAP
1996-09-13Labeling · Supplement 23 · standardAP
1996-03-13Efficacy · Supplement 7AP
1995-08-30Manufacturing (CMC) · Supplement 20 · standardAP
1994-06-30Labeling · Supplement 19 · standardAP
1993-10-18Labeling · Supplement 15AP
1993-06-28Manufacturing (CMC) · Supplement 16 · standardAP
1993-01-27Labeling · Supplement 11AP
1993-01-27Labeling · Supplement 13AP
1992-01-31Efficacy · Supplement 8AP
1992-01-31Manufacturing (CMC) · Supplement 14 · standardAP
1991-08-19Labeling · Supplement 6AP
1991-08-19Labeling · Supplement 9AP
1991-08-19Labeling · Supplement 5AP
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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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