NDA 214012

NOVARTIS PHARMS CORP

FDA Drug Application

Application #214012

Documents

• Label: 2021-12-23
• Letter: 2021-12-23
• Review: 2022-01-20
• Letter: 2022-06-07
• Label: 2022-06-10

Application Sponsors

NDA 214012

NOVARTIS PHARMS CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

284MG/1.5ML

2

LEQVIO

INCLISIRAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-12-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-01-26	STANDARD

Submissions Property Types

ORIG	1	Null	33
SUPPL	2	Null	15

TE Codes

001

Prescription

TBD

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
        )

)