ANDA 202766

XELLIA PHARMS APS

FDA Drug Application

Application #202766

Application Sponsors

ANDA 202766

XELLIA PHARMS APS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500,000 UNITS BASE/VIAL

0

POLYMYXIN B SULFATE

POLYMYXIN B SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-01-15

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202766
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLYMYXIN B SULFATE","activeIngredients":"POLYMYXIN B SULFATE","strength":"EQ 500,000 UNITS BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-01-15
        )

)