NOVARTIS PHARMS CORP FDA Approval NDA 215039

NDA 215039

NOVARTIS PHARMS CORP

FDA Drug Application

Application #215039

Documents

Letter2022-04-06
Label2022-04-07

Application Sponsors

NDA 215039NOVARTIS PHARMS CORP

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET; ORAL50MG0VIJOICEALPELISIB
002TABLET; ORAL125MG0VIJOICEALPELISIB
003TABLET; ORAL200MG0VIJOICEALPELISIB

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not ConsolidatedORIG1AP2022-04-05PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

NOVARTIS PHARMS CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215039
            [companyName] => NOVARTIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIJOICE","activeIngredients":"ALPELISIB","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VIJOICE","activeIngredients":"ALPELISIB","strength":"125MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VIJOICE","activeIngredients":"ALPELISIB","strength":"200MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215039Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-05
        )

)

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