NOVO NORDISK INC FDA Approval NDA 215256

NDA 215256

NOVO NORDISK INC

FDA Drug Application

Application #215256

Documents

Label2021-06-07
Medication Guide2021-06-07
Letter2021-06-07

Application Sponsors

NDA 215256NOVO NORDISK INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001INJECTABLE;INJECTION0.25MG0WEGOVYSEMAGLUTIDE
002INJECTABLE;INJECTION0.5MG0WEGOVYSEMAGLUTIDE
003INJECTABLE;INJECTION1MG0WEGOVYSEMAGLUTIDE
004INJECTABLE;INJECTION1.7MG0WEGOVYSEMAGLUTIDE
005INJECTABLE;INJECTION2.4MG0WEGOVYSEMAGLUTIDE

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not ConsolidatedORIG1AP2021-06-04PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

NOVO NORDISK INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215256
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/215256s000lbl.pdf#page=26"]
            [products] => [{"drugName":"WEGOVY","activeIngredients":"SEMAGLUTIDE","strength":"0.25MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"WEGOVY","activeIngredients":"SEMAGLUTIDE","strength":"0.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"WEGOVY","activeIngredients":"SEMAGLUTIDE","strength":"1MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"WEGOVY","activeIngredients":"SEMAGLUTIDE","strength":"1.7MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"WEGOVY","activeIngredients":"SEMAGLUTIDE","strength":"2.4MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/04\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215256s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215256s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/215256Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-04
        )

)

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