LNK INTL INC FDA Approval ANDA 204872

ANDA 204872

LNK INTL INC

FDA Drug Application

Application #204872

Documents

Letter2017-01-27

Application Sponsors

ANDA 204872LNK INTL INC

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL220MG0NAPROXEN SODIUMNAPROXEN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2017-01-23

Submissions Property Types

ORIG1Null7

CDER Filings

LNK INTL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204872
            [companyName] => LNK INTL INC
            [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":"01\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204872Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-23
        )

)

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