NOVARTIS PHARMS CORP FDA Approval NDA 214012

NDA 214012

NOVARTIS PHARMS CORP

FDA Drug Application

Application #214012

Documents

Label2021-12-23
Letter2021-12-23

Application Sponsors

NDA 214012NOVARTIS PHARMS CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION284MG/1.5ML2LEQVIOINCLISIRAN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-12-22STANDARD

Submissions Property Types

ORIG1Null33

TE Codes

001PrescriptionTBD

CDER Filings

NOVARTIS PHARMS CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214012
            [companyName] => NOVARTIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEQVIO","activeIngredients":"INCLISIRAN","strength":"284MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214012lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214012Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-22
        )

)

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