ANDA 203540

HETERO LABS LTD III

FDA Drug Application

Application #203540

Application Sponsors

ANDA 203540

HETERO LABS LTD III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

400MG

0

RALTEGRAVIR

RALTEGRAVIR

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-09-30

Submissions Property Types

ORIG

1

Null

19

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203540
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"RALTEGRAVIR","activeIngredients":"RALTEGRAVIR","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-30
        )

)