NDA 019422

XTTRIUM

FDA Drug Application

Application #019422

Documents

• Letter: 2004-12-30
• Letter: 2009-02-27
• Letter: 2009-02-27
• Letter: 2012-12-18
• Letter: 2003-12-23
• Label: 2014-01-14
• Review: 2007-07-09
• Letter: 2017-09-19
• Label: 2019-02-06
• Letter: 2019-02-13

Application Sponsors

NDA 019422

XTTRIUM

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

2%

1

EXIDINE

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1985-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-07-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1996-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1996-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1997-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1998-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1998-10-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-10-08	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2003-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2004-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2009-02-25	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2009-02-25	N/A
LABELING; Labeling	SUPPL	43	AP	2012-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2016-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	2016-04-11	STANDARD
LABELING; Labeling	SUPPL	47	AP	2017-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2019-01-25	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	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	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	33	Null	0
SUPPL	43	Null	6
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	6

CDER Filings

XTTRIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19422
            [companyName] => XTTRIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXIDINE","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/25\/2019","submission":"SUPPL-49","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019422Orig1s049Lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2012","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019422Orig1s043lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXIDINE","submission":"CHLORHEXIDINE GLUCONATE","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-25
        )

)