ANDA 209017

AUROBINDO PHARMA LTD

FDA Drug Application

Application #209017

Application Sponsors

ANDA 209017

AUROBINDO PHARMA LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

FOR SOLUTION;ORAL

17GM/SCOOPFUL

0

POLYETHYLENE GLYCOL 3350

POLYETHYLENE GLYCOL 3350

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-12-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209017
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLYETHYLENE GLYCOL 3350","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-04-09
        )

)