ANDA 205685

XELLIA PHARMS APS

FDA Drug Application

Application #205685

Application Sponsors

ANDA 205685

XELLIA PHARMS APS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1.2GM BASE/VIAL

0

TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-09-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205685
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 1.2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-16
        )

)