NDA 50590, held by Glaxosmithkline. Clavulanate Potassium; Ticarcillin Disodium.
As of Nov 13, 2026, NDA 50590 (Timentin), held by Glaxosmithkline, was first approved by FDA on Apr 1, 1985, with 56 approved supplements and 0 published complete response letters.
| Dec 11, 1997 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 17, 1991 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Oct 23, 1987 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Apr 1, 1985 | Original applicationNew combination · Priority review | Approved | None posted |
| TimentinEQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL · injectable;injection | Clavulanate Potassium; Ticarcillin Disodium | Discontinued |
| TimentinEQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL · injectable;injection | Clavulanate Potassium; Ticarcillin Disodium | Discontinued |
| TimentinEQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL · injectable;injection | Clavulanate Potassium; Ticarcillin Disodium | Discontinued |
| Jun 12, 2014 | Supplement 69Labeling · Standard review | Approved | |
| Feb 12, 2014 | Supplement 68Manufacturing · Priority review | Approved | None posted |
| Sep 27, 2013 | Supplement 67Labeling · Standard review | Approved | |
| Jul 19, 2013 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Mar 20, 2013 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Oct 4, 2012 | Supplement 62Labeling · Standard review | Approved | |
| Jun 9, 2011 | Supplement 60Labeling · Standard review | Approved | |
| Jun 9, 2011 | Supplement 61Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 58Labeling · Standard review | Approved | |
| Dec 20, 2010 | Supplement 59Labeling · Standard review | Approved | |
| May 8, 2008 | Supplement 55Labeling · Standard review | Approved | |
| Apr 17, 2008 | Supplement 57Labeling · Standard review | Approved | |
| Mar 15, 2007 | Supplement 54Labeling · Standard review | Approved | |
| Nov 19, 2004 | Supplement 52Labeling · Standard review | Approved | |
| Jan 3, 2003 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Oct 17, 2002 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| May 17, 2002 | Supplement 27Labeling · Standard review | Approved | |
| Mar 18, 2002 | Supplement 40Labeling · Standard review | Approved | |
| Feb 8, 2002 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Aug 16, 2001 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Aug 2, 2001 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| Aug 2, 2001 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Nov 19, 1999 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Sep 23, 1999 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jul 7, 1999 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Feb 1, 1999 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1998 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Dec 11, 1997 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 29, 1997 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Jun 17, 1997 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Feb 27, 1996 | Supplement 29Labeling · Standard review | Approved | None posted |
| Jan 19, 1996 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 18, 1995 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Sep 16, 1994 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1993 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jun 8, 1993 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Jan 7, 1993 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 26, 1992 | Supplement 20Labeling | Approved | None posted |
| Mar 26, 1992 | Supplement 19Labeling | Approved | None posted |
| Jan 2, 1992 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Dec 17, 1991 | Supplement 16Efficacy (new indication or use) | Approved | None posted |
| Feb 26, 1990 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Apr 20, 1989 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Apr 20, 1989 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 24, 1988 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| May 16, 1988 | Supplement 12Labeling | Approved | None posted |
| Dec 1, 1987 | Supplement 21Labeling | Approved | None posted |
| Oct 23, 1987 | Supplement 10Efficacy (new indication or use) | Approved | None posted |
| Aug 18, 1987 | Supplement 11Labeling | Approved | None posted |
| Feb 14, 1986 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1985 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1985 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 12, 1985 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| May 13, 1985 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Apr 19, 1985 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Apr 18, 1985 | Supplement 3Labeling | Approved | None posted |
| Apr 1, 1985 | Original applicationNew combination · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
