← FDA DRUG APPROVALS

FDA NDA · NDA050672

CEFTIN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA050672
TYPE
NDA
ORIGINAL APPROVAL
1994-06-30
LATEST ACTION
2021-03-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEFTIN · ReferenceDiscontinued
CEFUROXIME AXETIL EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
CEFTIN · ReferenceDiscontinued
CEFUROXIME AXETIL EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2021-03-05Labeling · Supplement 38 · standard — Letter ↗AP
2019-04-25Labeling · Supplement 37 · standard — Letter ↗AP
2017-10-13Labeling · Supplement 36 · standard — Label ↗AP
2016-11-22Labeling · Supplement 35 · standard — Letter ↗AP
2015-08-26Labeling · Supplement 34 · standard — Label ↗AP
2015-06-26Labeling · Supplement 33 · standard — Label ↗AP
2014-09-20Labeling · Supplement 32 · standard — Label ↗AP
2014-09-20Labeling · Supplement 29 · standard — Label ↗AP
2007-08-01Labeling · Supplement 28 · standard — Label ↗AP
2004-06-03Labeling · Supplement 25 · standard — Label ↗AP
2002-04-11Labeling · Supplement 18 · standard — Label ↗AP
2002-03-29Labeling · Supplement 13 · standard — Letter ↗AP
2001-09-18Manufacturing (CMC) · Supplement 21 · standardAP
2001-07-03Manufacturing (CMC) · Supplement 19 · standardAP
2001-04-13Manufacturing (CMC) · Supplement 20 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 17 · standardAP
1999-08-24Efficacy · Supplement 14 · standard — Review ↗AP
1999-07-27Manufacturing (CMC) · Supplement 3 · standardAP
1999-04-23Manufacturing (CMC) · Supplement 16 · standardAP
1999-03-02Manufacturing (CMC) · Supplement 15 · standardAP
1998-03-24Labeling · Supplement 12 · standardAP
1997-11-19Manufacturing (CMC) · Supplement 11 · standardAP
1997-06-04Labeling · Supplement 10 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 8 · standardAP
1996-12-23Labeling · Supplement 9 · standardAP
1996-12-23Labeling · Supplement 4 · standardAP
1996-09-13Labeling · Supplement 5 · standardAP
1996-09-13Labeling · Supplement 1 · standardAP
1995-12-14Labeling · Supplement 2AP
1995-11-09Labeling · Supplement 7 · standardAP
1995-08-08Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-30Type 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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