ANDA 209235

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209235

Documents

• Letter: 2018-01-08

Application Sponsors

ANDA 209235

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

0

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209235
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209235s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-01
        )

)