MARKSANS PHARMA FDA Approval ANDA 091416

ANDA 091416

MARKSANS PHARMA

FDA Drug Application

Application #091416

Application Sponsors

ANDA 091416MARKSANS PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL250MG0NAPROXENNAPROXEN
002TABLET;ORAL375MG0NAPROXENNAPROXEN
003TABLET;ORAL500MG0NAPROXENNAPROXEN

FDA Submissions

ORIG1AP2011-02-14

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91416
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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