NDA 215039

NOVARTIS PHARMS CORP

FDA Drug Application

Application #215039

Documents

• Letter: 2022-04-06
• Label: 2022-04-07
• Letter: 2022-11-18
• Label: 2022-11-18
• Review: 2022-11-21

Application Sponsors

NDA 215039

NOVARTIS PHARMS CORP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET; ORAL	50MG	0	VIJOICE	ALPELISIB
002	TABLET; ORAL	125MG	0	VIJOICE	ALPELISIB
003	TABLET; ORAL	200MG	0	VIJOICE	ALPELISIB

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated

ORIG

1

AP

2022-04-05

PRIORITY

Submissions Property Types

ORIG

1

Null

6

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
        )

)