ANDA 209413

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209413

Documents

• Letter: 2018-11-16

Application Sponsors

ANDA 209413

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

50MG

0

MIRABEGRON

MIRABEGRON

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-10-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209413
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRABEGRON","activeIngredients":"MIRABEGRON","strength":"50MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/12\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209413Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-12
        )

)