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FDA NDA · NDA050590

TIMENTIN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA050590
TYPE
NDA
ORIGINAL APPROVAL
1985-04-01
LATEST ACTION
2014-06-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TIMENTINDiscontinued
CLAVULANATE POTASSIUM EQ 1GM BASE/VIAL, TICARCILLIN DISODIUM EQ 30GM BASE/VIAL · INJECTABLE · INJECTION
TIMENTINDiscontinued
CLAVULANATE POTASSIUM EQ 100MG BASE/VIAL, TICARCILLIN DISODIUM EQ 3GM BASE/VIAL · INJECTABLE · INJECTION
TIMENTINDiscontinued
CLAVULANATE POTASSIUM EQ 200MG BASE/VIAL, TICARCILLIN DISODIUM EQ 3GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2014-06-12Labeling · Supplement 69 · standard — Letter ↗AP
2014-02-12Manufacturing (CMC) · Supplement 68 · priorityAP
2013-09-27Labeling · Supplement 67 · standard — Letter ↗AP
2013-07-19Manufacturing (CMC) · Supplement 66 · priorityAP
2013-03-20Manufacturing (CMC) · Supplement 65 · priorityAP
2012-10-04Labeling · Supplement 62 · standard — Label ↗AP
2011-06-09Labeling · Supplement 61 · standard — Label ↗AP
2011-06-09Labeling · Supplement 60 · standard — Label ↗AP
2010-12-20Labeling · Supplement 59 · standard — Label ↗AP
2010-12-20Labeling · Supplement 58 · standard — Letter ↗AP
2008-05-08Labeling · Supplement 55 · standard — Letter ↗AP
2008-04-17Labeling · Supplement 57 · standard — Label ↗AP
2007-03-15Labeling · Supplement 54 · standard — Label ↗AP
2004-11-19Labeling · Supplement 52 · standard — Letter ↗AP
2003-01-03Manufacturing (CMC) · Supplement 48 · priorityAP
2002-10-17Manufacturing (CMC) · Supplement 47 · priorityAP
2002-05-17Labeling · Supplement 27 · standard — Letter ↗AP
2002-03-18Labeling · Supplement 40 · standard — Letter ↗AP
2002-02-08Manufacturing (CMC) · Supplement 44 · priorityAP
2001-08-16Manufacturing (CMC) · Supplement 43 · priorityAP
2001-08-02Manufacturing (CMC) · Supplement 41 · priorityAP
2001-08-02Manufacturing (CMC) · Supplement 42 · priorityAP
1999-11-19Manufacturing (CMC) · Supplement 37 · priorityAP
1999-09-23Manufacturing (CMC) · Supplement 36 · priorityAP
1999-07-07Manufacturing (CMC) · Supplement 32 · priorityAP
1999-02-01Manufacturing (CMC) · Supplement 35 · priorityAP
1998-02-05Manufacturing (CMC) · Supplement 34 · priorityAP
1997-12-11Efficacy · Supplement 30 · standardAP
1997-08-29Manufacturing (CMC) · Supplement 33 · priorityAP
1997-06-17Manufacturing (CMC) · Supplement 31 · priorityAP
1996-02-27Labeling · Supplement 29 · standardAP
1996-01-19Labeling · Supplement 25 · standardAP
1995-04-18Manufacturing (CMC) · Supplement 28 · priorityAP
1994-09-16Manufacturing (CMC) · Supplement 26 · priorityAP
1993-06-08Manufacturing (CMC) · Supplement 23 · priorityAP
1993-06-08Manufacturing (CMC) · Supplement 24 · priorityAP
1993-01-07Labeling · Supplement 22 · standardAP
1992-03-26Labeling · Supplement 20AP
1992-03-26Labeling · Supplement 19AP
1992-01-02Manufacturing (CMC) · Supplement 18 · priorityAP
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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