ANDA 203307

LUPIN LTD

FDA Drug Application

Application #203307

Application Sponsors

ANDA 203307

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-27

Submissions Property Types

ORIG

1

Null

17

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203307
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUDOVRA","activeIngredients":"ESTRADIOL VALERATE;ESTRADIOL VALERATE;DIENOGEST","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-27
        )

)