ANDA 208815

ACTAVIS LABS FL INC

FDA Drug Application

Application #208815

Application Sponsors

ANDA 208815

ACTAVIS LABS FL INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

50MG

0

ELTROMBOPAG

ELTROMBOPAG

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-11-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208815
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELTROMBOPAG","activeIngredients":"ELTROMBOPAG","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-28
        )

)