ANDA 209014

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209014

Application Sponsors

ANDA 209014

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-06-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209014
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE","activeIngredients":"CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE","strength":"1MG;10MCG;10MCG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/08\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-08
        )

)