NDA 212154

NIPPON SHINYAKU CO LTD

FDA Drug Application

Application #212154

Documents

• Label: 2020-08-13
• Letter: 2020-08-13
• Review: 2020-08-31
• Label: 2021-03-12
• Letter: 2021-03-12

Application Sponsors

NDA 212154

NIPPON SHINYAKU CO LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MG/5ML

2

VILTEPSO

VILTOLARSEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-12	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2021-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15

CDER Filings

NIPPON SHINYAKU CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212154
            [companyName] => NIPPON SHINYAKU CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VILTEPSO","activeIngredients":"VILTOLARSEN","strength":"250MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212154s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212154s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-12
        )

)