ANDA 208415

AUROBINDO PHARMA LTD

FDA Drug Application

Application #208415

Documents

• Letter: 2017-07-13

Application Sponsors

ANDA 208415

AUROBINDO PHARMA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

5MG

0

LINAGLIPTIN

LINAGLIPTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-06-16

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208415
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN","activeIngredients":"LINAGLIPTIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/16\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208415TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-16
        )

)