ANDA 211500

MYLAN LABS LTD

FDA Drug Application

Application #211500

Application Sponsors

ANDA 211500

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION;INTRAVENOUS

300MG/16.7ML (18MG/ML)

0

POSACONAZOLE

POSACONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211500
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"300MG\/16.7ML (18MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-28
        )

)