ANDA 211059

AUROBINDO PHARMA LTD

FDA Drug Application

Application #211059

Application Sponsors

ANDA 211059

AUROBINDO PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

UNKNOWN

UNKNOWN

0

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

LOPERAMIDE HYDROCHLORIDE;SIMETHICONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211059
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE","activeIngredients":"LOPERAMIDE HYDROCHLORIDE; SIMETHICONE","strength":"2MG;125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-14
        )

)