IMPAX LABS FDA Approval ANDA 209810

ANDA 209810

IMPAX LABS

FDA Drug Application

Application #209810

Documents

Letter2020-09-22

Application Sponsors

ANDA 209810IMPAX LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL2.5MG0APIXABANAPIXABAN
002TABLET; ORAL5MG0APIXABANAPIXABAN

FDA Submissions

UNKNOWN; ORIG1TA2020-08-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209810
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209810Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-19
        )

)

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