ANDA 208931

AUROBINDO PHARMA LTD

FDA Drug Application

Application #208931

Application Sponsors

ANDA 208931

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

SYRUP;ORAL

1MG/ML

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-06-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208931
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"1MG\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-29
        )

)