ASCEND LABORATORIES LLC FDA Approval ANDA 211761

ANDA 211761

ASCEND LABORATORIES LLC

FDA Drug Application

Application #211761

Documents

Letter2020-09-22

Application Sponsors

ANDA 211761ASCEND LABORATORIES LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG0APREMILASTAPREMILAST
002TABLET; ORAL20MG0APREMILASTAPREMILAST
003TABLET; ORAL30MG0APREMILASTAPREMILAST

FDA Submissions

UNKNOWN; ORIG1TA2020-08-21STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ASCEND LABORATORIES LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211761
            [companyName] => ASCEND LABORATORIES LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APREMILAST","activeIngredients":"APREMILAST","strength":"30MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211761Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-21
        )

)

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