PLIVA FDA Approval ANDA 074242

ANDA 074242

PLIVA

FDA Drug Application

Application #074242

Application Sponsors

ANDA 074242PLIVA

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORALEQ 250MG BASE0NAPROXEN SODIUMNAPROXEN SODIUM
002TABLET;ORALEQ 500MG BASE0NAPROXEN SODIUMNAPROXEN SODIUM

FDA Submissions

ORIG1AP1996-06-20

Submissions Property Types

SUPPL1Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74242
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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