ANDA 207983

AUROBINDO PHARMA LTD

FDA Drug Application

Application #207983

Documents

• Letter: 2019-03-12

Application Sponsors

ANDA 207983

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

FINGOLIMOD

FINGOLIMOD

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-02-07

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207983
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FINGOLIMOD","activeIngredients":"FINGOLIMOD","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/07\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207983Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-07
        )

)