ANDA 210963

LAURUS LABS LTD

FDA Drug Application

Application #210963

Application Sponsors

ANDA 210963

LAURUS 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

2019-05-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LAURUS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210963
            [companyName] => LAURUS 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":"05\/16\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-16
        )

)