ANDA 216204

AUROBINDO PHARMA LTD

FDA Drug Application

Application #216204

Application Sponsors

ANDA 216204

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

38MG;200MG

0

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

DIPHENHYDRAMINE CITRATE; IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-05-31

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216204
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND DIPHENHYDRAMINE CITRATE","activeIngredients":"DIPHENHYDRAMINE CITRATE; IBUPROFEN","strength":"38MG;200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-31
        )

)