NEXGEN PHARMA FDA Approval ANDA 090812

ANDA 090812

NEXGEN PHARMA

FDA Drug Application

Application #090812

Application Sponsors

ANDA 090812NEXGEN PHARMA

Marketing Status

Over-the-counter001

Application Products

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

FDA Submissions

ORIG1AP2009-10-07

Submissions Property Types

ORIG1Null7

CDER Filings

LGM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90812
            [companyName] => LGM 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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POLYETHYLENE GLYCOL 3350","submission":"POLYETHYLENE GLYCOL 3350","actionType":"17GM\/SCOOPFUL","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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