MARKSANS PHARMA FDA Approval ANDA 091237

ANDA 091237

MARKSANS PHARMA

FDA Drug Application

Application #091237

Application Sponsors

ANDA 091237MARKSANS PHARMA

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL200MG0IBUPROFENIBUPROFEN

FDA Submissions

ORIG1AP2011-02-08
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2016-02-08UNKNOWN

Submissions Property Types

ORIG1Null7
SUPPL2Null15

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91237
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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