BLA 761180

LEO PHARMA AS

FDA Drug Application

Application #761180

Documents

• Label: 2021-12-28
• Letter: 2021-12-28
• Review: 2022-01-25
• Letter: 2022-07-28

Application Sponsors

BLA 761180

LEO PHARMA AS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

0

ADBRY

TRALOKINUMAB

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2021-12-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-07-27	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

CDER Filings

LEO PHARMA AS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761180
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADBRY","activeIngredients":"TRALOKINUMAB","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761180s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761180s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761180Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-27
        )

)