ANDA 213120

LUPIN LTD

FDA Drug Application

Application #213120

Application Sponsors

ANDA 213120

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2023-01-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213120
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOLUTEGRAVIR; RILPIVIRINE","activeIngredients":"DOLUTEGRAVIR;RILPIVIRINE","strength":"50MG\/25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/13\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-13
        )

)