NDA 215256

NOVO NORDISK INC

FDA Drug Application

Application #215256

Documents

• Label: 2021-06-07
• Medication Guide: 2021-06-07
• Letter: 2021-06-07
• Review: 2021-12-27
• Label: 2022-08-29
• Label: 2022-12-27
• Medication Guide: 2022-12-27
• Letter: 2022-12-27

Application Sponsors

NDA 215256

NOVO NORDISK INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	INJECTABLE;INJECTION	0.25MG	0	WEGOVY	SEMAGLUTIDE
002	INJECTABLE;INJECTION	0.5MG	0	WEGOVY	SEMAGLUTIDE
003	INJECTABLE;INJECTION	1MG	0	WEGOVY	SEMAGLUTIDE
004	INJECTABLE;INJECTION	1.7MG	0	WEGOVY	SEMAGLUTIDE
005	INJECTABLE;INJECTION	2.4MG	0	WEGOVY	SEMAGLUTIDE

FDA Submissions

TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated	ORIG	1	AP	2021-06-04	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2022-08-24	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	6

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
        )

)