ANDA 213557

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213557

Application Sponsors

ANDA 213557

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213557
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETIRIZINE HYDROCHLORIDE","activeIngredients":"CETIRIZINE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-11
        )

)