ANDA 209632

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209632

Application Sponsors

ANDA 209632

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG;0.02MG

0

LO-ZUMANDIMINE

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-02-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209632
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LO-ZUMANDIMINE","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL","strength":"3MG;0.02MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-27
        )

)