NDA 050658

GLAXOSMITHKLINE

FDA Drug Application

Application #050658

Documents

• Letter: 2002-03-18
• Letter: 2004-12-02
• Letter: 2008-12-19
• Letter: 2010-12-28
• Letter: 2011-06-13
• Letter: 2014-06-17
• Label: 2007-03-16
• Label: 2008-06-05
• Label: 2010-12-26
• Label: 2011-06-14
• Label: 2012-10-05
• Label: 2013-10-01
• Label: 2014-06-17
• Letter: 2007-03-23
• Letter: 2008-04-22
• Letter: 2012-10-09
• Letter: 2013-10-01

Application Sponsors

NDA 050658

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/100ML;EQ 3GM BASE/100ML

0

TIMENTIN IN PLASTIC CONTAINER

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-12-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-09-15	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-09-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-11-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2002-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2003-01-03	STANDARD
LABELING; Labeling	SUPPL	18	AP	2004-11-19	STANDARD
LABELING; Labeling	SUPPL	20	AP	2007-03-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	2008-05-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2008-04-17	STANDARD
LABELING; Labeling	SUPPL	23	AP	2010-12-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2011-06-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2012-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-05-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	2013-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2014-05-14	STANDARD
LABELING; Labeling	SUPPL	31	AP	2014-06-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	6
SUPPL	24	Null	6
SUPPL	25	Null	6
SUPPL	28	Null	0
SUPPL	29	Null	15
SUPPL	30	Null	0
SUPPL	31	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50658
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMENTIN IN PLASTIC CONTAINER","activeIngredients":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","strength":"EQ 100MG BASE\/100ML;EQ 3GM BASE\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/12\/2014","submission":"SUPPL-31","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-29","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-25","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-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050658s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-23","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-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050658s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050590s054,050658s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TIMENTIN IN PLASTIC CONTAINER","submission":"CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM","actionType":"EQ 100MG BASE\/100ML;EQ 3GM BASE\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2014-06-12
        )

)