NDA 019125

XTTRIUM

FDA Drug Application

Application #019125

Documents

• Letter: 2012-11-13
• Letter: 2005-05-18
• Letter: 2014-10-22
• Review: 2003-09-11
• Label: 2014-10-30
• Letter: 2017-09-19
• Label: 2017-09-21
• Letter: 2022-09-30
• Label: 2022-10-05

Application Sponsors

NDA 019125

XTTRIUM

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

4%

0

EXIDINE

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-09-04	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1989-12-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1995-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1996-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1996-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1996-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1996-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1998-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1999-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1999-10-08	STANDARD
LABELING; Labeling	SUPPL	34	AP	2005-05-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2012-11-09	STANDARD
LABELING; Labeling	SUPPL	42	AP	2014-10-17	STANDARD
LABELING; Labeling	SUPPL	44	AP	2017-09-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2022-09-29	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	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	30	Null	0
SUPPL	31	Null	0
SUPPL	40	Null	7
SUPPL	42	Null	7
SUPPL	44	Null	6

CDER Filings

XTTRIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19125
            [companyName] => XTTRIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXIDINE","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"4%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/14\/2017","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019125Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2014","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019125Orig1s042lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXIDINE","submission":"CHLORHEXIDINE GLUCONATE","actionType":"4%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-09-14
        )

)