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FDA NDA · NDA050658

TIMENTIN IN PLASTIC CONTAINER

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA050658
TYPE
NDA
ORIGINAL APPROVAL
1989-12-15
LATEST ACTION
2014-06-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TIMENTIN IN PLASTIC CONTAINERDiscontinued
CLAVULANATE POTASSIUM EQ 100MG BASE/100ML, TICARCILLIN DISODIUM EQ 3GM BASE/100ML · INJECTABLE · INJECTION

Approval history

2014-06-12Labeling · Supplement 31 · standard — Letter ↗AP
2014-05-14Manufacturing (CMC) · Supplement 30 · standardAP
2013-09-27Labeling · Supplement 29 · standard — Label ↗AP
2013-05-29Manufacturing (CMC) · Supplement 28 · standardAP
2012-10-04Labeling · Supplement 25 · standard — Label ↗AP
2011-06-09Labeling · Supplement 24 · standard — Letter ↗AP
2010-12-20Labeling · Supplement 23 · standard — Letter ↗AP
2008-05-08Labeling · Supplement 21 · standard — Letter ↗AP
2008-04-17Labeling · Supplement 22 · standard — Label ↗AP
2007-03-15Labeling · Supplement 20 · standard — Label ↗AP
2004-11-19Labeling · Supplement 18 · standard — Letter ↗AP
2003-01-03Manufacturing (CMC) · Supplement 16 · standardAP
2002-10-17Manufacturing (CMC) · Supplement 15 · standardAP
2002-03-18Labeling · Supplement 9 · standard — Letter ↗AP
2002-02-08Manufacturing (CMC) · Supplement 12 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 11 · standardAP
2001-08-02Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-19Manufacturing (CMC) · Supplement 7 · standardAP
1999-09-23Manufacturing (CMC) · Supplement 6 · standardAP
1999-02-01Manufacturing (CMC) · Supplement 5 · standardAP
1996-02-27Labeling · Supplement 4 · standardAP
1996-01-19Labeling · Supplement 2 · standardAP
1994-09-15Manufacturing (CMC) · Supplement 3 · standardAP
1992-12-22Manufacturing (CMC) · Supplement 1 · standardAP
1989-12-15Type 3 - New Dosage Form · Original · standardAP
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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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