SUN PHARM INDS LTD FDA Approval ANDA 091183

ANDA 091183

SUN PHARM INDS LTD

FDA Drug Application

Application #091183

Application Sponsors

ANDA 091183SUN PHARM INDS LTD

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL220MG0NAPROXEN SODIUMNAPROXEN SODIUM

FDA Submissions

ORIG1AP2011-05-20

Submissions Property Types

ORIG1Null7

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91183
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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