ANDA 203177

XELLIA PHARMS APS

FDA Drug Application

Application #203177

Application Sponsors

ANDA 203177

XELLIA PHARMS APS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50,000 UNITS/VIAL

0

BACITRACIN

BACITRACIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-08-25

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203177
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACITRACIN","activeIngredients":"BACITRACIN","strength":"50,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/25\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-25
        )

)