STRIDES PHARMA FDA Approval ANDA 203928

ANDA 203928

STRIDES PHARMA

FDA Drug Application

Application #203928

Application Sponsors

ANDA 203928STRIDES PHARMA

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001FOR SOLUTION;ORAL17GM/SCOOPFUL0POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350
002FOR SOLUTION;ORAL17GM/PACKET0POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350

FDA Submissions

UNKNOWN; ORIG1AP2016-08-24

Submissions Property Types

ORIG1Null7

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203928
            [companyName] => STRIDES PHARMA
            [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"},{"drugName":"POLYETHYLENE GLYCOL 3350","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-24
        )

)

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