ANDA 077789

XTTRIUM

FDA Drug Application

Application #077789

Application Sponsors

ANDA 077789

XTTRIUM

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;DENTAL

0.12%

0

CHLORHEXIDINE GLUCONATE

CHLORHEXIDINE GLUCONATE

FDA Submissions

	ORIG	1	AP	2009-06-18
LABELING; Labeling	SUPPL	7	AP	2015-07-28	STANDARD

Submissions Property Types

SUPPL

7

Null

15

TE Codes

001

Prescription

AT

CDER Filings

XTTRIUM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77789
            [companyName] => XTTRIUM
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORHEXIDINE GLUCONATE","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"0.12%","dosageForm":"SOLUTION;DENTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORHEXIDINE GLUCONATE","submission":"CHLORHEXIDINE GLUCONATE","actionType":"0.12%","submissionClassification":"SOLUTION;DENTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)