NDA 019421

XTTRIUM

FDA Drug Application

Application #019421

Application Sponsors

NDA 019421

XTTRIUM

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;TOPICAL

2.5%

0

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	1988-05-10	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

XTTRIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19421
            [companyName] => XTTRIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXIDINE","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"2.5%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EXIDINE","submission":"CHLORHEXIDINE GLUCONATE","actionType":"2.5%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)