ANDA 761156

NOVO NORDISK INC

FDA Drug Application

Application #761156

Documents

• Letter: 2020-09-01
• Label: 2020-09-04
• Review: 2020-09-28
• Label: 2021-10-01
• Label: 2021-10-01
• Letter: 2021-10-05
• Letter: 2021-10-05

Application Sponsors

ANDA 761156

NOVO NORDISK INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/1.5ML

0

SOGROYA

SOMPACITAN-BECO

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

NOVO NORDISK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761156
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOGROYA","activeIngredients":"SOMPACITAN-BECO","strength":"10MG\/1.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761156Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-28
        )

)