ANDA 062691

GLAXOSMITHKLINE

FDA Drug Application

Application #062691

Application Sponsors

ANDA 062691

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

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

0

TIMENTIN

CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM

FDA Submissions

	ORIG	1	AP	1986-12-19
LABELING; Labeling	SUPPL	2	AP	1991-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-02-26
LABELING; Labeling	SUPPL	4	AP	1992-01-30
LABELING; Labeling	SUPPL	5	AP	1992-04-17
LABELING; Labeling	SUPPL	6	AP	1993-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-02-23
LABELING; Labeling	SUPPL	12	AP	1996-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-12-09
LABELING; Labeling	SUPPL	42	AP	2004-02-04
LABELING; Labeling	SUPPL	45	AP	2004-10-07
LABELING; Labeling	SUPPL	46	AP	2003-10-07
LABELING; Labeling	SUPPL	47	AP	2005-07-06
LABELING; Labeling	SUPPL	49	AP	2008-06-10
LABELING; Labeling	SUPPL	50	AP	2008-06-28
LABELING; Labeling	SUPPL	51	AP	2009-02-17
LABELING; Labeling	SUPPL	52	AP	2011-03-04
LABELING; Labeling	SUPPL	53	AP	2013-06-27
LABELING; Labeling	SUPPL	54	AP	2013-06-27

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	53	Null	15
SUPPL	54	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62691
            [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"}]
            [labels] => 
            [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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)