ANDA 209407

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209407

Application Sponsors

ANDA 209407

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

3MG;0.03MG

0

ZUMANDIMINE

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209407
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZUMANDIMINE","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-26
        )

)