Documents
Application Sponsors
| NDA 050590 | GLAXOSMITHKLINE | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL | 0 | TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM |
| 002 | INJECTABLE;INJECTION | EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL | 0 | TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM |
| 003 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL | 0 | TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1985-04-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1985-04-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 1985-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-08-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-11-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-11-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-02-14 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 1987-10-23 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1987-08-18 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1988-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1988-08-24 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1989-04-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1989-04-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1991-12-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1990-02-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1992-01-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1992-03-26 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1992-03-26 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1987-12-01 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1993-01-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1993-06-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1993-06-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 1996-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1994-09-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 27 | AP | 2002-05-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-04-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 29 | AP | 1996-02-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 30 | AP | 1997-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1997-06-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1999-07-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1997-08-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1998-02-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1999-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1999-09-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1999-11-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 40 | AP | 2002-03-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2001-08-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 2001-08-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 2001-08-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2002-02-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 2002-10-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 2003-01-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 2004-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2007-03-15 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2008-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 57 | AP | 2008-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2010-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2010-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 60 | AP | 2011-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 61 | AP | 2011-06-09 | STANDARD |
| LABELING; Labeling | SUPPL | 62 | AP | 2012-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2013-03-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 66 | AP | 2013-07-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 67 | AP | 2013-09-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 68 | AP | 2014-02-12 | PRIORITY |
| LABELING; Labeling | SUPPL | 69 | AP | 2014-06-12 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 52 | Null | 9 |
| SUPPL | 58 | Null | 6 |
| SUPPL | 59 | Null | 6 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 6 |
| SUPPL | 62 | Null | 6 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 6 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 50590
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"TIMENTIN","activeIngredients":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","strength":"EQ 100MG BASE\/VIAL;EQ 3GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TIMENTIN","activeIngredients":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","strength":"EQ 200MG BASE\/VIAL;EQ 3GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TIMENTIN","activeIngredients":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","strength":"EQ 1GM BASE\/VIAL;EQ 30GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/12\/2014","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050590s069,050658s031lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2013","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050590s067,050658s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2012","submission":"SUPPL-62","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050590s062,050658s025lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050590s060s061lbl.pdf\"}]","notes":""},{"actionDate":"06\/09\/2011","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050590s060s061lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050658s023,050590s058,050590s059lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050658s023,050590s058,050590s059lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2008","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050590s057lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2007","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050590s054,050658s020lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TIMENTIN","submission":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","actionType":"EQ 100MG BASE\/VIAL;EQ 3GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TIMENTIN","submission":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","actionType":"EQ 200MG BASE\/VIAL;EQ 3GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TIMENTIN","submission":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","actionType":"EQ 1GM BASE\/VIAL;EQ 30GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2014-06-12
)
)