ANDA 209602

MYLAN LABS LTD

FDA Drug Application

Application #209602

Application Sponsors

ANDA 209602

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

50MG

0

DOLUTEGRAVIR SODIUM

DOLUTEGRAVIR SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209602
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)