ANDA 203113

LUPIN LTD

FDA Drug Application

Application #203113

Application Sponsors

ANDA 203113

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

1MG;0.01MG;75MG

0

LO-BLISOVI FE

NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-05-12

Submissions Property Types

ORIG

1

Null

19

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203113
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LO-BLISOVI FE","activeIngredients":"NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE","strength":"1MG;0.01MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-05-12
        )

)