ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART FDA Approval NDA 215833

NDA 215833

ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

FDA Drug Application

Application #215833

Documents

Label2022-03-23
Letter2022-03-24
Review2022-04-19

Application Sponsors

NDA 215833ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1000 MBQ/ML (27MCI/ML)0PLUVICTOLUTETIUM (177LU) VIPIVOTIDE TETRAXETAN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-03-23PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215833
            [companyName] => ADVANCED ACCELERATOR APPLICATIONS USA INC A NOVART
            [docInserts] => ["",""]
            [products] => [{"drugName":"PLUVICTO","activeIngredients":"LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN","strength":"1000 MBQ\/ML (27MCI\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215833s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215833s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215833Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)

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