ANDA 210676

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210676

Application Sponsors

ANDA 210676

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210676
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN","strength":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-14
        )

)