NDA 213182

NOVO NORDISK INC

FDA Drug Application

Application #213182

Documents

• Label: 2020-01-17
• Medication Guide: 2020-01-17
• Letter: 2020-01-17
• Review: 2020-06-29

Application Sponsors

NDA 213182

NOVO NORDISK INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	3MG	2	RYBELSUS	SEMAGLUTIDE
002	TABLET;ORAL	7MG	2	RYBELSUS	SEMAGLUTIDE

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2020-01-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

NOVO NORDISK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213182
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/213182s000,213051s001lbl.pdf#page=23"]
            [products] => [{"drugName":"RYBELSUS","activeIngredients":"SEMAGLUTIDE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"RYBELSUS","activeIngredients":"SEMAGLUTIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/16\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213182s000,213051s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213182s000,213051s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213182Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-16
        )

)