NDA 019127

XTTRIUM

FDA Drug Application

Application #019127

Documents

• Letter: 2013-04-16
• Letter: 2009-06-23
• Letter: 2017-09-19
• Label: 2017-09-21

Application Sponsors

NDA 019127

XTTRIUM

Marketing Status

• Over-the-counter: 001

Application Products

001

AEROSOL, METERED;TOPICAL

4%

1

EXIDINE

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1997-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2009-06-16	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2012-07-11	STANDARD
LABELING; Labeling	SUPPL	20	AP	2013-04-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2017-09-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	7
SUPPL	22	Null	6

CDER Filings

XTTRIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19127
            [companyName] => XTTRIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXIDINE","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"4%","dosageForm":"AEROSOL, METERED;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/14\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019127Orig1s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"EXIDINE","submission":"CHLORHEXIDINE GLUCONATE","actionType":"4%","submissionClassification":"AEROSOL, METERED;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-09-14
        )

)